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Unknown taper.Medwatch sent to fda on 12/29/2015.The reporter of the event was asked to return the product for analysis, and to indicate the product's serial number.The reporter indicated the device would not be returned, and to date apollo has not received any further device information.Without the device or device serial number, the connecter type associated with this event cannot be determined.This event was reported by the patient.Follow-up with the patient's explanting physician confirmed the patient's report.Additional information regarding the device serial number, as well as diagnostic testing information and dates have been requested of the patient's physicians.To date, apollo has not received any additional information.Device labeling addresses the reported events as follows: warnings: failure to secure the band properly may result in its subsequent displacement and necessitate a second operation.Patients should be advised that the lap-band 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: failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.Care must be taken to avoid damaging the band, its inflatable section or tubing, the access port or the calibration tube.Use only rubber-shod clamps to clamp tubing.Failure to use the tubing end plug during placement of the band may result in damage to the band tubing during band placement.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.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included:.Abdominal pain,.Gi perforation.
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Supplement #1 - medwatch sent to fda on 02/17/2016.Apollo endosurgery received a letter of request from fda dated 31-dec-2015 for additional information regarding mdr report number 3006722112-2015-00597.(b)(4).Response to fda request: if the device did not function or perform as expected, please describe which device function or feather did not perform as intended, and the manner in which the device did not function as expected.Additionally, please discuss whether the unexpected function or behavior resulted in the event described.Response: the device was not returned for analysis, so a complete investigation could not be performed.Based on the report provided, the device did not function as intended.The tubing connecting the access port to the band portion of the device became detached at an unknown location, and subsequently the tubing wrapped around the colon and perforated the colon.The detachment of the tubing is believed to have resulted in the event reported.Describe the parts or components of the devices that detached from the device.Provide a schematic of the reported device(s) and indicate where on the schematic the detachment occurred.Response: the tubing portion of the device became detached, exact location unknown.The schematic of the device is provided in attachment 1 of this report.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, and if the life expectancy varies under certain conditions: response: the lap-band ap® adjustable gastric banding system with omniform design 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 not withstanding 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 provide further explanation regarding how you determined the conclusion(s) code(s) reported in your medical device report.Response: the fda conclusion code - device not returned.The code was chosen as the device was not available for return and analysis, as reported by the explanting physician's office.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: an explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual: response: follow-up with initial reporter (the patient) as well as the explanting physician to request return of the device found the device was not available for analysis, therefore the root cause for this device failure could not be determined.Follow-up did determine that the patient ultimately did not have a cancer diagnosis, as was originally reported.The suspected tumor wrapped around the patient's colon was determined to be the lap-band tubing, as shown in the images provided in the surgical pathology report.The explanting physician has confirmed the patient's report.Follow-up also found the additional report that the patient suffered from an occluded colon and a perforation of their colon by the detached lap-band tubing.The reason for this occurrence could not be determined based on our follow-up with the reporting facility or individual.A complete description of investigation and analysis methodology(ies) used: response: the methodology used for this investigation included a review of all reported information, interviews and follow up with the complainant, and a labeling evaluation, as per apollo process.The device was not returned, thus no device analysis could be performed.Serial number was not given, though it has been requested of the patient, explanting physician, implanting physician, and implanting institution.Without serial number, a review of manufacturing records could not be performed.An identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved: response: as the device was not returned, a specific failure mode could not be confirmed.Any conclusions reached based on the investigation and analysis results: response: root cause cannot be determined as the device was not returned for analysis.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: a complete list of medical device reports (mdrs) that we have determined are related to this same problem/issue is below.Eleven (11) mdrs in addition to the one for which this response is written have been filed for the issue of colon occlusion or body part perforation by disconnected lap-band tubing.Mdr report number 2024601-2006-00602, 2024601-2006-00636, 2024601-2007-00400, 2024601-2008-00769, 2024601-2009-00159, 2024601-2011-00100, 2024601-2011-00539, 2024601-2012-00133, 2024601-2012-00416, 2024601-2012-00525, 2024601-2012-00822.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).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 specific sampling procedures.Response: the inspections discussed in this response focus on the failure modes that could occur in the region identified above for question 2.Apollo performs incoming and in-process inspection activities for the following design features related to the tubing: no holes and tears: incoming 100% visual inspection of lap-band components including tubing.Leak test: incoming 100% leak test of lap-band component.The port component supplier(s) performs leak checks on 100% of components.The testing includes the port and attached tubing.Provide the results of any testing your firm has completed that validates that this component meets the needs of the user.Response: one of the user needs of the lap-band system is that it must be safe and effective for long term placement.The lap-band has over 19 years of clinical use, as it was first marketed ous in 1996 and then in the us in 2001.Apollo's most recent clinical evaluation report for the lap-band system and accessories summarizes the clinical history and supports the conclusions that the existing system and accessories meet this user need.If any design changes or corrections have already been implemented, please provide the date that these were implemented, as well as a description of the change and/or correction.Response: not applicable - there have been no design changes to the device or corrections implemented.
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