PORCINE AORTIC VALVE PROSTHESIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-09 for PORCINE AORTIC VALVE PROSTHESIS manufactured by Carpentier-edwards.

Event Text Entries

[21955171] Valve is probably a carpentier-edwards; however, all attempts at positive identification have been unsuccessful. Patient was treated for mitral valve endocarditis approxomately 3 mo. Prior to surgery. Patient presented with recent onset increasing chest pain and congestive failure cardiac cath. Showed 3+ aortic insufficiency and possible perivalvular leak. Surgery revealed multiple holes within the porcine valve leadflets, but no discrete perivalvular leak. There was what apeared to be vegetations present on the valve leaflets as well. Unfortunately, the valve was discarded. Pathology report and slides have been included with this reort. Invalid data - regarding single use labeling of device. Patient medical status prior to event: critical condition. 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: component failure, leaflet. Conclusion: device failure related to patient condition. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7472
• MDR Report Key: 7472
• Date Received: 1994-02-09
• Date of Report: 1993-09-22
• Date Facility Aware: 1993-05-19
• Report Date: 1993-09-22
• Date Reported to Mfgr: 1993-09-22
• Date Added to Maude: 1994-04-25
• 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: NI
• Generic Name: PORCINE AORTIC VALVE PROSTHESIS
• Product Code: ISP
• Date Received: 1994-02-09
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: OTHER CAREGIVERS
• Device Availability: N
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 7153
• Manufacturer: CARPENTIER-EDWARDS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-02-09