MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. DUAL COLLAPSER (FOR VALVE SIZE 25, 27); TISSUE HEART VALVE/ ACCESSORY

Model Number ICV1348

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

A complete manufacturing and material records review for the accessory has been performed.The results confirmed that the accessory satisfied all material, visual and performance standards required at the time of manufacture and release.

Event Description

The manufacturer received a notification on apr.25, 2018 involving a failure to implant.It was reported that the site experienced difficulty mounting the valve correctly with the holder and collapser.The site reported no patient impact and stated another valve and accessory kit were used.The valve and dual collapser have been sent for analysis.This report concerns the accessory kit.A related report livanova (b)(4) pertains to the aforementioned valve.

Manufacturer Narrative

The returned accessories appeared in general good conditions except the dual holder silicon cap that was found damaged.After decontamination, the accessories were visually inspected without highlight any particular elements of not conformity according to the specifications or pre-existing defects.A simulation of collapsing phases was performed in order to attempt to replicate the reported event, according to the indication included in the ifu (perceval ¿ sutureless aortic heart valve ¿ instructions for use ¿ ic0215001345 rev.J).For a complete investigation the simulation was performed with the returned valve and accessory kit.In addition, the collapsing simulation was repeated restoring the silicon cap of the returned holder in order to replicate the collapsing procedure with all the accessories having the correct configuration.The simulation of the valve collapsing, performed with the returned device and using the returned accessory kit (in both conditions as was and with the restored cap), was successfully completed according to the current procedure.No anomalous behaviors were observed during both the collapsing procedures.Based on the performed analysis, the reported issue is not related to factors intrinsic in the involved device (etq 2018-02462) or related accessories (etq 2018-02452).

• Brand Name: DUAL COLLAPSER (FOR VALVE SIZE 25, 27)
• Type of Device: TISSUE HEART VALVE/ ACCESSORY
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7546796
• MDR Text Key: 109488564
• Report Number: 3005687633-2018-00161
• 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: 06/22/2018

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?: No
• Device Operator: Physician
• Device Model Number: ICV1348
• Device Lot Number: 1705080066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization