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Unknown taper medwatch sent to the fda on 12/30/2016 this event was reported by the patient's child.To date, apollo has been unable to confirm the reported events with the patient's physician.The patient's child at the times of follow up did not have any physician information or additional patient information.As there was not an autopsy, apollo's approach to compliance is to resolve all doubt in favor of reporting.Device labeling addresses the reported events as follows: precautions: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Perforation of the stomach can occur.Death can also occur.Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain.Obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.Infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.Warnings: laparoscopic or laparotomic placement of the lap-band ap system is major surgery and death can occur.
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Supplement #1 - medwatch sent to fda on 02/13/2017.Additional information: additional mfr narrative.Apollo endosurgery received a letter of request from the fda dated december 30, 2016 for additional information regarding mdr report number: 3006722112-2016-00389.Attn: (b)(6).Response to fda request: please provide the disposition of the device, including information on your efforts to acquire or have the device returned for the investigation.For reusable devices, indicate whether the device is still in use.Response: the disposition of the device is unknown at this time.An apollo safety nurse spoke with the reporter of the event, the daughter of the patient, on december 2, 2016, and twice on december 30, 2016.In each instance, the reporter was unable to provide the patient's implanting physician or treating physician name or contact information, therefore apollo has been unable to investigate if the device is available for return.The lap-band is a single use device, therefore the device is no longer in use.Describe the parts or components of the devices that slipped.Provide a schematic of the reported device(s) and indicate where on the schematic the slippage occurred.Response: please see attachment 1 for a schematic of the lap-band.Limited information has been received regarding the reported event, the exact location of where the events occurred is unknown.Please confirm or provide the model, lot, serial and/or catalog number(s) of the device listed in the medical device report as applicable.Response: apollo has been unable to gather the device catalog number, lot or serial number.The patient's child has indicated to apollo that this information is not known to them, in addition, does not know the name of the implanting physician, or treating physician.Please provide the device implant and explant dates, and/or the duration of implant time.If the implant was explanted, please provide the reason.Response: the daughter of the patient indicated the lap-band had been implanted approximately one year prior to their passing ("she didn't even have it a year").Attempts to gather more information from the patient's child were unsuccessful.Please provide the life expectancy and anticipated failure rate for the device, including life expectancy and failure rate of any critical power source or component, such as a battery.Please explain how the life expectancy and/or failure rate information is communicated to users of the device.Additionally, please state how the failure rate was determined, as life expectancy varies under certain conditions.Response: the lap-band ap adjustable gastric banding system directions for use (dfu) available online states: "the manufacturer of the lap-band ap adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and notwithstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component failure and normal wear and tear.In addition, the lap-band ap system may be easily damaged by improper handling or use.Please refer to the adverse events section in this document and to the information for patients booklet for a presentation of the warnings, precautions, and the possible adverse events associated with the use of the lap-band ap adjustable gastric banding system." additionally, the product dfu states: "it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body." as the device was not returned for analysis, the failure mode associated with this complaint cannot be determined.Without a specific failure mode, the failure rate for the reported event cannot be determined.Please describe any design change(s) or modification(s) to the device, since the device was initially introduced to the market that may be related to the event.Please also include the date(s) the design change(s) or modification(s) occurred.Response: as the device catalog, serial or lot number is unknown, in addition to the event being unconfirmed with a healthcare professional, apollo at this time does not have sufficient information to make this determination.Please provide the total number of devices manufactured, distributed and if available, used per year over the last three years for the medical device identified in the medical device report.Please indicate the proportions distributed in the us and outside of the us.Response: currently, apollo does not track the number of devices used per year, therefore this information is not available.Total sales of devices plus units manufactured (not including accessories) are listed below: (b)(4).Please provide any evaluation of the event described in the medical device report by the attending physician, surgeon, hospital representative, or health care professional.Response: apollo has been unable to confirm the reported events with a healthcare professional.The patient's child has indicated they do not know their parent's physician information, and indicated at this time no additional information would be forthcoming.Please fully describe the reported device malfunction.Describe any relevant alarm states and visual and/or audible indicators the device should present with a malfunction of this nature occurs.Response: the daughter of the patient reported that their parent passed away on (b)(6) 2016.The reporter stated the cause of death was due to a "multi-series of events." the daughter of the patient also reported that the: "band slipped, restricting, bowel blockage, gangrene, stomach started expanding, the doctor went to cut or remove the device and she died instantly." no autopsy was performed.Apollo has been unable to confirm these events with a healthcare professional, therefore cannot determine if or how the device malfunctioned.As per the directions for use (dfu), "band slippage and/or pouch dilation can occur" and "more serious slippages with severe abdominal pain and persistent nausea and vomiting require prompt medical attention and may require surgery to remove the band." in addition, "obstruction of stoma has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food." the onset of persistent nausea and vomiting and severe or progressive abdominal pain may be due to band slippage and stoma obstruction.These alarm states warrant immediate medical attention as noted in the dfu.Please provide all relevant information which your firm used to determine that the reported event is occurring with greater or lesser frequency and/or severity, than is stated in the labeling for the device, or expected (i.E.Where the device labeling is silent on event frequency and severity).In your response, please provide the expected and observed frequency and severity for the reported event with this device, and as applicable, the family of devices it belongs to.Response: apollo's approach to compliance is to resolve all doubts in favor of reporting.As there has been very limited information received regarding the nature of the patient's death, and what factor, if any, the device contributed, a frequency rate could not be calculated.Please provide any evaluation of the other information used by your firm to determine whether the events described in the medical device report are or are not attributable to the device.Response: at this time, apollo has been provided limited information for this reported event.As per the reporter, an autopsy was not performed after the patient's passing.With limited information regarding the event and no information identifying the specific device (e.G.No lot/serial number), no additional information about the possible presence of device issues is known.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: response: the results of this investigation are inconclusive.An explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual the device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been received, including a copy of the autopsy report, as an autopsy was not performed.A device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.A complete description of investigation and analysis methodology(ies) used, neither device analysis, nor review of manufacturing records was possible for this case, as the device was not returned and the device id information is not known.The investigation included interviews with the reporter/ child of the patient.A review of apollo's device labeling for this reported event was performed.The current lap-band ap adjustable gastric banding system directions for use (dfu) addresses the known and anticipated potential events of "death", "band slippage", "obstruction", "infection", and "bloating" as follows: "over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation." "it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body." "perforation of the stomach can occur.Death can also occur.Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound." "ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures." "band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain." "obstruction of stoma has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food." "infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated." "other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection." "laparoscopic or laparotomic placement of the lap-band ap system is major surgery and death can occur." an identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and as apollo cannot determine if or how the event was device related based on limited communication from the reporter, it is not possible to determine if or how a specific failure mode could have contributed to this event.Any conclusions reached based on the investigation and the analysis results.Assessment of the device involved in this complaint was not possible.It has not been possible to determine a root cause for the reported event.The events of death, band slippage, obstruction, infection, and bloating are known and labeled possible adverse events.This type of complaint will continue to be monitored.Please provide a complete list of medical device reports (mdrs) that you have determined are related to this same problem/issue.Please identify how many complaints (i.E.From all sources, including but not limited to field service records, repair history records, etc.) that your firm has received in the past 2 years that are related to this same reported device problem.Response: apollo was unable to determine the root cause of the event, as the device was not returned for analysis, and therefore the specific device problem for this complaint is unknown.For that reason, apollo is unable at this time to determine how many complaints (i.E.From all sources, including but not limited to field service records, repair history records, etc.) that our firm has received in the past 2 years that are related to this same reported device problem (interpreted as root cause for device failure).However, apollo has submitted the below mdrs from january 1, 2015 to january 1, 2017 for the reported event of "death": mdr: 2024601-2015-00134; manufacturer (b)(4).Mdr: 3006722112-2016-00389; manufacturer (b)(4).Please identify the exact location in the labeling where users are warned of steps to take to prevent the bowel obstruction and gangrene from occurring, and/or how to mitigate the problem should it occur.If bowel obstruction and gangrene are not listed in your labeling, are you willing to update your labeling? what actions will you take? response: as per the lap-band ap adjustable gastric banding system directions for use (dfu): "description (page 1): the lap-band ap adjustable gastric banding system with omniform design is the latest advance in laparoscopic adjustable gastric banding for the treatment of morbid obesity.The initial pouch and stoma sizes are established through the use of the calibration tube.The inner surface of the band is inflatable and connected by kink-resistant tubing to the access port, which is included in the lap-band ap system.This permits post-operative, percutaneous, stoma-size adjustment.Dietary and behavior modification counseling and frequent, long-term follow-up are required for all patients after weight-loss surgery.Intended use/indications (page 1): it is indicated for use only in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs.Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.Warnings (page 1): patients should be advised that the lap-band ap system is a long-term implant.Explant (removal) and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.Precautions (page 2): it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.Revision procedures may require the existing staple line to be partially disrupted to avoid having a second point of obstruction below the band.As with any revision procedure, the possibility of complications such as erosion and infection is increased.Any damage to the stomach during the procedure may result in peritonitis and death or in late erosion of the device into the gi tract.If fluid has been added, it is important to establish that the stoma is not too small before discharge.Care must be taken to not add too much saline, thereby closing the stoma.Check the adjustment by having the patient drink water.If the patient is unable to swallow, remove some fluid from the port, then re-check.A physician familiar with the adjustment procedure must be available for several days post-adjustment to deflate the band in case of an obstruction.It is the responsibility of the surgeon to advise the patient of the dietary restrictions that follow this procedure and to provide diet and behavior modification support.Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight.Patients must be carefully counseled on the need for proper dietary habits.They should be evaluated for nutritional (including caloric) needs and advised on the proper diet selection.The physician may choose to prescribe appropriate dietary supplements.Appropriate physical monitoring and dietary counseling should take place regularly.Patients must be cautioned to chew their food thoroughly.Patients with dentures must be cautioned to be particularly careful to cut their food into small pieces.Failure to follow these precautions may result in vomiting, stomal irritation and edema, possibly even obstruction.Patients must be seen regularly during periods of rapid weight loss for signs of malnutrition, anemia or other related complications.Patients who become pregnant, severely ill, or who require more extensive nutrition may require deflation of their bands.Insufficient weight loss may be caused by pouch enlarge-ment or, more infrequently, band erosion in which case further inflation of the band would not be appropriate.Adverse events (page 2 and page 3): it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain.Obstruction of stoma has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.Infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated." as per apollo's chief medical officer, stoma obstruction is handled in the existing dfu and obviously pertains to the constricted distal portion of the pouch.Bowel obstruction- this is clinically a very different scenario.It may not pertain to the band.It is commonly a reference to obstruction distal to the stomach.Gastric obstruction can occur at the outlet, i.E.The pylorus, due to ulcer disease (acute or chronic), tumor, and foreign bodies.Gastric obstruction proximal to the pylorus may be due to a postoperative state (post resection with an obstructed anastomosis) or due to volvulus (twisting; extremely rare) or entrapment of a paraesophageal hernia.If we are to address the broader topic of bowel obstruction, then this would require language such that the surgical manipulation of the stomach during placement of the band or slippage of the band may result in obstruction of the stomach at the level of the pouch and/or band.Complete obstruction may progress to impairing the viability of the organ similar to that seen when bowel obstruction occurs distal to the stomach with the development of ischemia and necrosis.The esophagus is largely a bystander in this interplay.Complete obstruction of the stoma results in pouch distention with accumulated fluids and progression to pouch ischemia with necrosis.Accompanying symptoms include persistent nausea and vomiting with escalating abdominal pain.Immediate medical attention is required with band deflation and may require surgical removal of the band and possible resection of the stomach.Changes to our labeling undergo review as part of our firm's annual risk management review process, we will evaluate potential changes to the labeling based on annual review of the risk profile of this on-market device and its existing labeling.Any potential/proposed changes in the labeling would be subject to prospective fda approval and/or inclusion into the annual report to the fda.What quality control procedures and testing does your firm employ to ensure outgoing product meets design and performance specifications? describe acceptance and rejection criteria, and specify sampling procedures.Response: apollo performs incoming and in-process inspection activities for the following design features of the lap-band device: incoming visual inspection 100% for: -no embedded particle, fiber, or bubble larger than.010 inches on concave surface of the shell.-no metallic particle on concave surface of the shell.-no embedded particle, fiber, or bubble larger than.020 inches on convex surface and edge of the shell.-no hole or tear, no nick, void, burn, short shot, or sharp corner on the inner ring and the shell.-no flash exceeding.010 inches.-inner ring tabs are trimmed flush with shell, no protrusion greater than.010 inches from shell.Incoming physical inspection: -100% dimensional thickness measurements are performed at 3 randomly selected band segment locations -100% inspection of drawing critical dimensions -tensile testing for band shell break force and ultimate elongation are performed at an aql of 4.0 where the break force is greater-than or equal to 2.5 lbf and elongation is greater-than or equal to 450% -100% leak check is performed -functional testing performed at an aql of 4.0 to determine the force to close belt and buckle where the acceptable force is less-than or equal to 7.4 lbs -functional testing performed at an aql of 4.0 to determine the force to pull apart the belt and buckle where the acceptable force is greater-than or equal to 10 lbs 100% visual inspection of packaging post sterilization please provide the primary and secondary cause of death as it was reported by the patient's physician, as it appears in the medical record or as it is described in the autopsy report.Please include the information source used in your response.Response: at this time, no additional information beyond the initial report has been received.An autopsy was not performed, as per the reporter.Apollo has been unable to confirm the report with a healthcare professional.Please provide the results of risk management activities completed by your firm which address the reported device problem.Indicate the frequency and severity of the hazard, cause(s), and the applicable control(s) implemented to mitigate the hazard.Response: as apollo has received limited information on the exact nature of the complaint, confirmed the event with a healthcare professional, or obtained specific device identification, no review of risk documentation related to frequency, and severity can be completed.Please provide the results of any testing your firm has completed that validates that this design/feature meets the needs of the user.Response: as apollo has received limited information on the exact nature of the complaint and been unable to confirm the event with a healthcare professional or obtained any device identification, we are unable to identify an applicable design validation with the information as provided.
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