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

Model Number PVS25

Device Problems Difficult to Fold, Unfold or Collapse (1254); Perivalvular Leak (1457)

Patient Problem No Information (3190)

Event Date 11/28/2018

Event Type  Injury  

Event Description

A perceval pvs25 was implanted on (b)(6) 2018.It was reported that the surgeon had some difficulty collapsing the valve.After several tries to collapse the valve, the valve looked imperfect on the holder and the stent was reportedly not symmetrical.The valve was implanted, and the visual aspect then appeared correct.It was stated that after decannulation, while the patient was in icu, a leak was identified.Re-operation was performed and the valve was explanted and replaced with a trifecta valve (size unknown).It was reported that there was a "crimping defect" of the valve; however, it could not be confirmed that the valve was folded at the time of re-operation.It was reported that the valve may not have been correctly implanted in the annulus.

Manufacturer Narrative

A complete review of the manufacturing and quality control data filed in the device history record of the perceval heart valve prosthesis, pvs 25/l, sn (b)(4), confirmed that the valve satisfied all material, dimensional and performance standards required for a size 25/l perceval heart valve at the time of manufacture and release.The valve was received in non-standard packaging conditions in a dry, under-sized jar.The pericardium was darkened and slightly dehydrated, although the leaflets were pliable.Visual inspection of the returned device, although partly dehydrated, did not reveal any anomalies attributable to pre-existing manufacturing defects.An attempt was made to simulate the reported issue; however, the dehydrated state of the returned device rendered the simulation of the reported event impossible.Due to the deeply altered state of the valve, an exhaustive investigation of the reported event could not be performed and the root cause of the event cannot be established.However, based on the document review performed, no manufacturing deficiencies were identified.

• 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: 8182192
• MDR Text Key: 130991723
• Report Number: 3005687633-2018-00236
• 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
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention