MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC ULTRA PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305U2J19

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Hematoma (1884)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 immediately post implant of this 19mm bioprosthetic aortic valve, echocardiogram revealed regurgitation.The patient's chest was re-opened, and it was discovered that one of the bioprosthetic leaflets was torn.It was reported that the physician believed there might have been a "pinhole" in the leaflet originally, and then after implant the pressure exerted on the leaflets from flowing blood caused the pinhole to progress to a tear.The valve was explanted and replaced with a non-medtronic bioprosthetic valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination showed the right and non-coronary cusps intact and in the partially closed position.The left cusp was open towards the outflow rail.An approximately 8mm linear tear was noted on the lunula of the left cusp, consistent with laceration by a sharp instrument.An intracuspal hematoma was noted on the non-coronary cusp, which appears to have occurred during explant.All commissures appeared intact.Conclusions: 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.Multiple downstream manufacturing checkpoints would have identified the 8mm linear tear.The 8mm linear tear likely occurred during the implant procedure, which is likely the source of the regurgitation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC ULTRA PORCINE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9723094
• MDR Text Key: 181395606
• Report Number: 2025587-2020-00503
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 305U2J19
• Device Catalogue Number: 305U2J19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention