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 Erosion (1750); Abdominal Distention (2601); Constipation (3274)

Event Date 03/04/2021

Event Type  Death  

Event Description

(b)(6) female presented as transfer, (b)(6) 2021 after 5 days of abdominal distension, no bm, fell at home.Ct with band erosion with multiple abscesses associated with the tubing.Band placed.Taken to or, laparotomy, drain multiple abscesses, band removal, gastric repair and drainage.Managed for sepsis with fluids, abx, nstemi mi on (b)(6) 2021.Subsequent pneumonia, intubation, pressor support.Family w/d support on (b)(6) 2021 as she continued to deteriorate and the patient expired.Implant date: 2008, explant date: (b)(6) 2021.Comorbitidities: obesity, back pain, myasthenia gravis.No information regarding lap-band part or serial number as the product was discarded prior to reporting to manufacturer.

• 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 ; 9494817801
• MDR Report Key: 11586120
• MDR Text Key: 242854674
• Report Number: 3013508647-2021-00010
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 03/29/2021
• 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; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 79