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

Model Number FR995-27

Device Problem Positioning Problem (3009)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Low Blood Pressure/ Hypotension (1914)

Event Date 11/15/2016

Event Type  Death  

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.(b)(4).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 during the implant of a transcatheter bioprosthetic valve, into a medtronic aortic root graft (implanted 15 years and 5 months prior) with severe aortic insufficiency and stenosis, the transcatheter bioprosthetic valve was positioned deep (approx.15-16mm).With the valve deployed to 80%, the leaflets appeared to be functioning properly, however the patient was hypotensive.Echocardiogram revealed a small left sided pericardial effusion.The valve was re-captured and removed from the patient, however the patient remained hypotensive.Cardiopulmonary resuscitation (cpr) was initiated.An attempt was made to insert an arterial cannula for cardiopulmonary bypass, but resistance was met.Shortly thereafter, a retroperitoneal bleed was noted and an iliac perforation was suspected.The chest was opened and a left ventricular perforation was found.Repair was attempted, however the patient died.Per the physician, the suspected cause of the pericardial effusion was a non-medtronic guidewire and the suspected cause of the iliac artery perforation was the arterial cannula that became stuck on a kinked non-medtronic guidewire.The manufacturer of the cannula was unable to be obtained.An autopsy indicated that the perforation in the ventricle was ¿small and unremarkable¿ and may not have contributed to the decrease in blood pressure.The physician suspected that the surgical root graft had been ¿disrupted¿ during the procedure resulting in increased aortic insufficiency, causing the hypotension, and was possibly exacerbated by the deep implant and/or the attempt to implant the transcatheter valve.It was also reported that there was a significant bend where the aortic root graft was attached to the aorta.

Manufacturer Narrative

Investigation: it was reported that fifteen years and five months post implant of this freestyle bioprosthetic valve, the valve had developed stenosis and regurgitation, and a valve-in-valve replacement was successfully performed.The patient died during the surgery due to a retroperitoneal bleed and an iliac perforation.An autopsy indicated that the perforation in the ventricle was ¿small and unremarkable¿ and may not have contributed to the decrease in blood pressure.The physician suspected that the surgical root graft had been ¿disrupted¿ during the procedure resulting in increased aortic insufficiency, causing the hypotension, and was possibly exacerbated by the deep implant and/or the attempts to implant the transcatheter valve.Conclusion: since the freestyle valve was implanted for over fifteen years before this product event, it¿s very unlikely that the reported stenosis and regurgitation are due to any potential manufacturing issue.Based on the reported information the cause of death was ascertained to be unrelated to the valve or its function.

Manufacturer Narrative

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.

• 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: 6170878
• MDR Text Key: 62259405
• Report Number: 2025587-2016-02009
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490265942
• UDI-Public: 00681490265942
• 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,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2004
• Device Model Number: FR995-27
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/1999
• 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
• Treatment: MODEL: ENVEOR-US/ LOT NUMBER: 0008179398
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 99