MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM VG WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number	B-2250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	07/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown taper.Medwatch sent to the fda on 01/26/2017.The reporter of the event was asked to return the product for analysis and it was indicated that the device could not be returned.Without the device, the taper type remains unknown.Device labeling addresses the reported events as follows: caution: the band should not be sutured to the stomach.Suturing the band directly to the stomach may result in erosion.As with other gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract.Any damage to the stomach during the procedure may result in erosion of the device into the gi tract.Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, should be used with caution.The use of such medications may be associated with an increased risk of erosion.Adverse events: 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.There is a risk of band erosion into stomach tissue.Erosion of the band into stomach tissue has been associated with revision surgery, after the use of gastric irritating medications, after stomach damage and after extensive dissection or use of electro-cautery, and during early experience.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection, or abdominal pain.Re-operation to remove the device is required.Special notice: the manufacturer of the lap-band® adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band® 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® system may be easily damaged by improper handling or use.
Event or Problem Description
Reported as: a patient with the lap-band system "presented to the hospital on [date] with a gi bleed.[patient] was placed on iv fluids, hemoglobin were trended and a protonix infusion was started.Gi was consulted and an egd was performed.The egd showed that the lap band had perforated through the gastric wall causing the bleeding.The patient was transferred to icu and a surgical consult was placed.Surgery decided to do a combined laparoscopic and endoscopic approach to remove the band and tubing.The band and tubing had eroded into the stomach and a portion of the duodenum.The patient had extensive adhesions." the device was removed.

• Brand Name: LAP-BAND SYSTEM VG WITH ACCESS PORT I
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 6281814
• Report Number: 3006722112-2017-00048
• Device Sequence Number: 1128591
• Product Code: LTI
• UDI-Device Identifier: 10811955020206
• UDI-Public: (01)10811955020206(11)070223(17)090222(10)1398336
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 02/22/2009
• Device Model Number: B-2250
• Device Catalogue Number: B-2250
• Device Lot Number: 1398336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80