MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA VALVE CONDUIT; MECHANICAL HEART VALVE

Model Number CP

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Failure of Implant (1924)

Event Date 11/25/2014

Event Type  Injury  

Event Description

The manufacturer was notified on (b)(6) 2014 that there was a failure to implant a carboseal valsalva valve conduit, size 27 (cp-027) due to reported difficulty to release the valve handle.During the maneuver, the disk of the mechanical valve broke off with the leaflet falling into the patient's left ventricle.The valve was explanted with the broken leaflet located and retrieved from the patient.Another similar device, size 25 (cp-025) was implanted instead without further incident.The patient was subsequently moved into the recovery room expecting normal outcomes.

Manufacturer Narrative

Result: the complete manufacturing and material records for the subject valve will be retrieved and reviewed by quality control at saluggia.The device will be evaluated upon return to the manufacturer.

• Brand Name: CARBOSEAL VALSALVA VALVE CONDUIT
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada per crescentino, sn; saluggia, 1304 0; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada per crescentino, sn; saluggia, 1304 0; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1 ; 4125696
• MDR Report Key: 4372350
• MDR Text Key: 5259929
• Report Number: 3005687633-2014-00007
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: CP
• Device Catalogue Number: CP-027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 77 YR