MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. ANNULOFLEX MITRAL ANNULOPLASTY RING

Model Number AF-836

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer is in the process of obtaining additional information about this event.Device disposition not presently known.

Event Description

It was reported that an annuloflex, size 36, was implanted and "removed" on (b)(6) 2018.No other information was provided.

Manufacturer Narrative

Based on the information received, the implanted ring was too small.The event is attributable to user error, and no further investigation is warranted.Updated fields: not required for investigation.

Event Description

An annuloflex size 36 was implanted.However, upon testing the repair there was mitral regurgitation and the ring was found to be too small, so the surgeon explanted the device and placed an alfieri stitch.Since a larger ring was not available, no ring was implanted.Tee showed trace to no mr, no ms, normal wall motion, normal ef.All findings were good.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7695120
• MDR Text Key: 114205042
• Report Number: 3005687633-2018-00175
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057013651
• UDI-Public: (01)08022057013651(240)AF-836(17)AA12
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023185
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2019
• Device Model Number: AF-836
• Device Catalogue Number: AF-836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2015
• 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: 67 YR