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

Model Number 305U

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that approximately two years, six months post implant of this bioprosthetic valve, this valve was explanted and replaced due to a perforated leaflet in the right coronary cusp of the valve.No adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the patient presented with exertional shortness of breath and was found to have congestive heart failure and severe aortic insufficiency prior to this valve replacement.The product has not been returned to medtronic for analysis, and without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The stent posts appeared slightly deflected.All leaflets were slightly stiff but flexible except where host tissue extends on the inflow.Tears and abrasions in all leaflets through the free margin and/or the lunula appeared to be due to contact with the bias cloth along the inner outflow rail or stent posts adjacent to all cusps.A tear along the lunula of the left cusp appeared to have increased in size during explant.All commissures appeared intact.Glistening off-white pannus remained attached to the existing sewing ring on the inflow adjacent to the non-coronary cusp extending along the tissue and base stitching, into all inferior coaptive areas, and 1 to 3 mm onto all cusps.Remnants of pannus were observed on the outflow and an unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography showed no evidence of mineralization in the valve and/or host tissue.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.Based on the received information and the returned product analysis, the reported regurgitation is most likely due to the cuspal tear/abrasion.

Manufacturer Narrative

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

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC 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
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5463740
• MDR Text Key: 39145587
• Report Number: 2025587-2016-00245
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• 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,Followup
• Report Date: 09/26/2016

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: 03/24/2018
• Device Model Number: 305U
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/26/2016
• Supplement Dates FDA Received: 03/02/2016; 09/29/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• 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: 00074 YR