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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING MITRAL ANNULOPLASTY RING

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SORIN GROUP ITALIA S.R.L MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING MITRAL ANNULOPLASTY RING Back to Search Results
Model Number MRCS34
Device Problem Inadequacy of Device Shape and/or Size
Event Date 06/30/2017
Event Type  Injury  
Manufacturer Narrative

As per medical judgment the physician has indicated that this was a sizing issue and that the event was not device related. Device not returned to manufacturer.

 
Event Description

On (b)(6) 2017 the manufacturer was notified through patient tracking of a memo 3d rechord semirigid annuloplasty ring that was implanted/explanted on (b)(6) 2017. Further information from the physician informed the manufacturer that the ring was implanted on (b)(6), during the procedure when the patient was coming off the pump, systolic anterior motion (sam) on echo was observed. The physician decided to put the patient back on pump and explant the device. A medtronic cg future band size 36 was then implanted. The patient is doing well following the surgery. An additional x clamp time of approx 20-30 minutes was added to the procedure.

 
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Brand NameMEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
Type of DeviceMITRAL 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,, vc 13040
IT  13040
Manufacturer Contact
francesca crovato
5005 north fraser way
burnaby, bc  V5J5M-1
  V5J5M1
MDR Report Key6786835
Report Number3005687633-2017-00081
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberMRCS34
Device Catalogue NumberICV1335
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/26/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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