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

Device Problems Material Erosion (1214); Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2021

Event Type  Injury  

Event Description

Doctor called reshape global clinical training director to tell him about a unique band event with one of his long term successful patients (2010).Unique in that it reported involves a port erosion into the colon - presented out the anus.Patient is stable.However, she is 36 weeks pregnant.He plans to remove the band after she delivers.

Manufacturer Narrative

No investigation is possible as the serial number, lot information and device was not available for return.

Event Description

Additional information received from surgeon: per the surgeon, "here is my theory.In 2015 i did a port replacement because she had excellent weight loss and her old port was protruding.I did a sub muscular placement of the new port which, since there is no fascia just the thin posterior sheath, the port actually can migrate through and into the colon without an infection appearing in the subcutaneous tissue." after the patient delivered a full-term healthy baby, the surgeon explanted the band (date unknown).The band was intact; and per the surgeon "nothing wrong with the band, just the tubing was in the colon." the surgeon removed the band and tubing and closed the fistula.The surgeon also did an egd (upper endoscopy) and the band was not eroded into the stomach.The band and tubing was discarded.The surgeon stated the patient has a "full uneventful recovery".

• 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: 12306202
• MDR Text Key: 265977618
• Report Number: 3013508647-2021-00029
• 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,Followup
• Report Date: 11/05/2021

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: 07/12/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 11/09/2021
• 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): Required Intervention; Other
• Patient Sex: Female