MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC GASTRIC LAPBAND

Device Problem Device Slipped (1584)

Patient Problems Vomiting (2144); Hernia (2240); Choking (2464); No Code Available (3191)

Event Date 01/04/2015

Event Type  Injury  

Event Description

I had the laparoscopic gastric banding done on (b)(6) 2010.On (b)(6) 2016, i began having burning in my nose while sleeping.Also had alot of burning and food coming up into mouth when burping.I returned to the surgeon who placed the lapband and under fluoroscopic examination it was determined that the lapband had slipped.I was instructed to consume only fluids for two weeks to see if band would go back into place.They did another fluoroscopic examination and band did not move.I did another two weeks of only fluids and still the band did not move.It was determined that the band needed to be removed because it could cut off the blood supply to my stomach.The lapband was removed on (b)(6) 2015.It was discovered i had a hiatal hernia caused by the band.While the lapband was in place i would often choke on meats and would need to vomit, even if i chewed really well.Other foods such as rice, pasta, raw vegetables would also get stuck.I would vomit 1-4 times a week.

• Brand Name: GASTRIC LAPBAND
• Type of Device: GASTRIC LAPBAND
• Manufacturer (Section D): APOLLO ENDOSURGERY INC
• MDR Report Key: 5917335
• MDR Text Key: 53704723
• Report Number: MW5064451
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 79