MAUDE Adverse Event Report: SORIN GROUP ITALY CARBOMEDICS STANDARD MITRAL VALVE; STANDARD SIZE 27 MITRAL

Model Number M7-027

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/23/2016

Event Type  malfunction  

Event Description

The manufacturer was notified of the following from patient tracking: on (b)(6) 2016, a m7-027 was implanted and then explanted.Another m7-027 was then implanted.No additional information has been provided.

Manufacturer Narrative

The valve was not available for return to the manufacturer for analysis.Based on the event information received, provided to (b)(4) by the hospital, the event was not device related and was based on physician medical judgment.Further debridement of annulus was required for avr.This valve was explanted to allow further debridement of the annulus , a new carbomedics valve of the same size was then implanted.Device not returned to manufacturer.

Event Description

On (b)(6) 2016, a (b)(4) was implanted and then explanted.More debridement of the annulus was performed.Another (b)(4) was then implanted.

• Brand Name: CARBOMEDICS STANDARD MITRAL VALVE
• Type of Device: STANDARD SIZE 27 MITRAL
• Manufacturer (Section D): SORIN GROUP ITALY; strada per crescentino; saluggia, vc
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; via crescentino snc; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6299963
• MDR Text Key: 66459978
• Report Number: 3005687633-2017-00002
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/03/2019
• Device Model Number: M7-027
• Device Catalogue Number: M7-027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2014
• 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): Required Intervention
• Patient Age: 45 YR