MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-20265

Device Problems Calcified (1077); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Patient Problem/Medical Problem (2688)

Event Date 11/11/2014

Event Type  Injury  

Manufacturer Narrative

Taper ii.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the serial number and implant date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Band restriction issues, pain, vomiting, intolerance and nausea are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.(b)(4).Device labeling addresses the reported event of band restriction issue as follows: "the lap-band ap system is available in two sizes, small and large.The physician should choose the appropriate size depending upon the patient's individual anatomy.After resolution of postoperative edema, most patients with appropriately placed bands report minimal if any restriction until saline is added to the band, regardless of the size used." device labeling addresses the potential for failure due to calcification as follows: ".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." device labeling addresses the reported events of pain, vomiting and nausea as follows: "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 band repositioning and/or removal.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." device labeling addresses the contraindication for patients regarding intolerance as follows: "patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system or who have exhibited pain intolerance to implanted devices.".

Event Description

Physician reported patient had intolerance to band and experienced nausea, vomiting and pain.Patient experienced band tightness and physician could not fill band.Explanted device showed calcifications on port band tubing.Device was not replaced and a roux-en-y bypass was done instead.Follow up findings: physician stated "patient very little compliant in treatment.Patient did not show up at several of the appointments given.".

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on 02/25/2016.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connecter type as taper ii.A visual analysis of the returned device was performed and noted the returned device to be separated into three pieces, the access port, a piece of the band tubing joined by the ss connector, and the lap-band itself.The band tubing was noted to have openings.The tubing was also noted to have residue present on the outer surface.An air leak test was performed on the access port, and no leakage was noted.A microscopic analysis was then performed on the tubing, and noted two striated openings; the striations were consistent with a surgical end cut for removal of the device.Microscopic analysis noted one unidentified opening on the band tubing which was attached to the ss connector.The lap-band was air leak tested, and no bubbles or openings were noted.A fill test was then performed, and no blockage of the port was noted.Intolerance is a physiological complication and analysis of the device generally does not assist apollo in determining a probable cause for this event.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, costa rica, cs ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5020919
• MDR Text Key: 23688291
• Report Number: 3006722112-2015-00261
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2008
• Device Catalogue Number: B-20265
• Device Lot Number: 1332371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR