GASTROESOPHOGEAL ANTIREFLUX VALVE - ANGELCHIK PROSTHESIS UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-17 for GASTROESOPHOGEAL ANTIREFLUX VALVE - ANGELCHIK PROSTHESIS UNKNOWN manufactured by Unknown.

Event Text Entries

[20685207] On 4/29/93, the patient was hospitalized with lower abdominal pain. The angelchik device had apparently come loose and migrated into the pevis at some previous date. The patient underwent surgery on 5/3/93 for sigmoid colon and upper rectal resection with low pelvic anastomosis, lysis of adhesions, extraction of migrated prosthesis, and left salpingo-oopherectomy. The patient expired 5/7/93. Device labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: material degradation/deterioration, telemetry failure, none or unknown. Conclusion: device failure occurred but not related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5134
• MDR Report Key: 5134
• Date Received: 1993-05-17
• Date of Report: 1993-05-10
• Date of Event: 1993-05-07
• Report Date: 1993-05-10
• Date Added to Maude: 1993-06-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GASTROESOPHOGEAL ANTIREFLUX VALVE - ANGELCHIK PROSTHESIS
• Product Code: ISP
• Date Received: 1993-05-17
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 4836
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-05-17