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

Model Number FR995-29

Device Problems Crack (1135); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Aortic Insufficiency (1715); Aortic Regurgitation (1716); Thrombus (2101); Cusp Tear (2656)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that five years post implant of this 29mm aortic bioprosthetic valve, the valve was explanted and replaced with a 23mm non-medtronic bioprosthetic valve due to aortic insufficiency.The report indicates there was suspicion of a partial "eruption" of the prosthesis in the region of the ascending aorta with suspicion of an aneurysm with thrombus in the false lumen.Upon removal of the valve, ¿cracks¿ were noted on the valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that three lesions were noted on the inside of the ascending aorta of this bioprosthetic valve; one close to the left coronary ostia (area of suspected aneurysm) and one on both the right and noncoronary sinuses.No aortic insufficiency was reported and the outside portion of the bioprosthetic valve did not have any lesions noted.The physician stated the valve was competent, however it needed to be removed due to "anatomical/surgical reasons".The physician also stated that the valve was damaged during the explant.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: 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.The device was not returned for analysis and no images were provided.Based on the reported clinical observation from the medical institution, the three lesions that were reported on the bioprosthetic valve (left coronary ostia, right sinus, and non-coronary sinus) may have potentially described a typical ¿pseudoaneurysm¿ which have historically occurred near the anastomotic site of the native coronary arteries to the valve.Medtronic conducted an extensive investigation regarding pseudoaneurysms which included re-examining the quality of the porcine tissue (tissue thickness), the tissue treatment process, and all subsequent manufacturing steps.The conclusion of medtronic¿s investigation was that pseudoaneurysm formation is not directly related to any limitations within the manufacturing process, and implant technique could be an important contributing factor.Based on the available information and with no returned product, the clinical observation of a suspected aneurysm with thrombus could not be confirmed and a conclusive root cause was unable to be determined.There was no information to indicate a device malfunction or a quality deficiency.Eval-code result added in section.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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7711069
• MDR Text Key: 114732401
• Report Number: 2025587-2018-01820
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2018
• Device Model Number: FR995-29
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• Date Device Manufactured: 02/22/2013
• 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: 54 YR
• Patient Weight: 80