MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS25

Device Problem Activation Failure (3270)

Patient Problem No Information (3190)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

The returned prosthesis valve was received in general good conditions.The returned accessories were received blood stained.Given that the surgeon apparently converted to full-sternotomy after the initial implant attempt, it is possible that the surgical approach contributed to the reported event.Additionally, given that a size 21 perimount valve was ultimately implanted, mis-sizing may also have been a contributing factor.

Event Description

A perceval valve was implanted on (b)(6) 2018.The physician stated that, during sizing, the large sizer passed through easily, while the medium (pvs25) sizer sat on the annulus.It was reported that the physician had difficulty removing the holder from the valve, but that the valve positioning looked good after it was removed.After weaning from bypass, paravalvular leak was identified.The aorta was then reopened, and folding of the valve was identified.The physician performed a full sternotomy, explanted the perceval valve and implanted a size 21 perimount valve.

Manufacturer Narrative

Valve was implanted via full sternotomy, not mini-sternotomy.

Event Description

A perceval valve was implanted on (b)(6) 2018 via full sternotomy.It was reported that the physician had difficulty removing the holder from the valve, but that the valve positioning looked good after it was removed.After weaning from bypass, paravalvular leak was identified.The aorta was then reopened, and folding of the valve was identified.The physician performed a full sternotomy, explanted the perceval valve and implanted a size 21 perimount valve.It was reported that the physician could also have implanted a size 23 perimount valve.The patient outcome was good.

Event Description

A perceval valve was implanted on (b)(6) 2018 via mini-sternotomy.It was reported that the physician had difficulty removing the holder from the valve, but that the valve positioning looked good after it was removed.After weaning from bypass, paravalvular leak was identified.The aorta was then reopened, and folding of the valve was identified.The physician performed a full sternotomy, explanted the perceval valve and implanted a size 21 perimount valve.The patient outcome was good.

Manufacturer Narrative

A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Visual inspection of the returned prosthesis did not reveal any elements of non-conformity.A collapsing simulation was performed, and the valve was successfully collapsed without observing any anomalies.A subsequent deployment simulation was performed, and did not reveal any anomalies.No paravalvular leak was identified after the valve was deployed.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic to the involved device.Given that a size 21 perimount valve was ultimately implanted, the event can reasonably be attributed to mis-sizing.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8052063
• MDR Text Key: 127363122
• Report Number: 3005687633-2018-00207
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 64