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

Model Number FR995

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Mitral Regurgitation (1964); Pseudoaneurysm (2605)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen was discarded by the user facility.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.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 3 years 6 months post implant of this aortic bioprosthetic valved root, a computed tomography (ct) scan showed leakage in the area of the device.The physician decided to explant and replace the device.During the explant procedure, the physician observed a pseudoaneurysm caused by a.5cm penetrating hole in diameter just lateral to the left main ostium in the left sinus of the bioprosthetic valved root.The sinus was thin and disintegrated easily with forceps.The space between the previously covered aorta and the root was full with old clots.The physician removed the clots, excised the device, and implanted a new device.No other adverse patient effects were reported.

Manufacturer Narrative

Conclusion: without the device returned to medtronic, any of the clinical observations cannot be confirmed.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Based on the received information, this event describes a typical pseudoaneurysm event.Medtronic previously conducted an extensive analysis / investigation which included re-examining the quality of the porcine tissue (tissue thickness), the tissue treatment process and all subsequent manufacturing steps.Based upon this analysis, it was concluded that pseudoaneurysm formation is not directly related to any limitations within the manufacturing process.Implant techniques, however, could be important contributing factors:misalignment of coronary arteries resulting in tension on the anastomotic site ¿failure to adequately mobilize the coronary buttons to prevent tension on the anastomoses.Over sizing the anastomotic site ¿ sewing to thin tissue as a result on creating an extensive or low button hole in the freestyle sinus.Iatrogenic (needle size too large), multiple unnecessary needle punctures at the wall and/or coronary button site.Surgical tissue adhesives like bioglue.While, the additional glutaraldehyde exposure from the bioglue to the freestyle tissue is irrelevant, as is the bioprosthesis is fully cross-linked, the glutaraldehyde component of the adhesive may have undesired effects on the native host tissue, including tissue necrosis.If information is provided in the future, a supplemental report will be issued.

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: 6640953
• MDR Text Key: 77556350
• Report Number: 2025587-2017-00967
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169008144
• UDI-Public: 00643169008144
• 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: 07/24/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2018
• Device Model Number: FR995
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 07/24/2017
• Supplement Dates FDA Received: 07/26/2017; 10/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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: 40 YR