MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995

Device Problems Calcified (1077); Material Rupture (1546)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis is in progress.Analysis results will be submitted in a supplemental report.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 15 years post implant of this aortic bioprosthetic valve, the device was explanted and replaced due to a leaflet tear and calcification.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, three excised leaflets and four loose tissue pieces were returned.All leaflets had been excised during explant.The orientation of leaflets was not known based on the receipt condition.All excised leaflets were slightly stiff but flexible except where pannus and/or calcification extended on the inflow and outflow aspects.Tissue deterioration due to visible calcification was observed on all three leaflets.Traces of glistening off white pannus observed to the margin of attachments of all excised leaflets.Pannus was observed on two of the loose tissue returned.Radiography revealed calcification in all three excised leaflets and on three of the loose tissue pieces.Conclusion: due to the receipt condition, the reported tear cannot be confirmed.Pannus overgrowth was observed.Also tissue deterioration due to calcification was observed on all three leaflets.Based on the received information and device analysis, the calcification could be the potential cause of the reported cuspal tear.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6771113
• MDR Text Key: 81948035
• Report Number: 2025587-2017-01320
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490816465
• UDI-Public: 00681490816465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2007
• Device Model Number: FR995
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2002
• 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
• Patient Age: 72 YR