MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Great Vessel Perforation (2152)

Event Type  Death  

Manufacturer Narrative

Attempts to contact the reporter for additional information were made; however, the reporter refused to provide more information.It was not confirmed if the adverse event happened during a bariatric procedure involved lap band or not; however, a report was made out of precaution.No investigation was performed.No information available regarding the product that was involved.Multiple attempts to obtain additional information for an investigation were unsuccessful.Unable to determine if the complaint is about the lap-band or about another band which was available in the us and phased out at the end of 2016.Unable to determine root cause or conduct trending analysis.No further action to be taken unless the patient responds with more information.No new risks identified, the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.The lot history record for the complaint was not available to be reviewed.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.If additional information would be available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.

Event Description

It was reported by the patient's parent that the patient passed away due to pulmonary embolism (pe).Per report, the patient experienced pe 2 weeks after the patient's iliac artery was punctured during procedure.It was not confirmed if the patient was receiving the bariatric procedure.No additional information was provided.

Event Description

Original report stated: it was reported by the patient's parent that the patient passed away due to pulmonary embolism (pe).Per report, the patient experienced pe 2 weeks after the patient's iliac artery was punctured during procedure.It was not confirmed if the patient was receiving the bariatric procedure.New information received from patient's parent clarified that the patient's iliac artery was punctured during the surgery to place the lap-band and that it was not implanted as a result of the puncture.Patient has respectfully requested no further contact be made regarding this event and no additional information was provided.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: brian stowe ; 1001 calle amanecer; san clemente, CA 92673 ; 9492764349
• MDR Report Key: 16184372
• MDR Text Key: 307483840
• Report Number: 3013508647-2022-00307
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death