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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO RING TRI-AD 900SFC28; RING, ANNULOPLASTY
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MEDTRONIC MEXICO RING TRI-AD 900SFC28; RING, ANNULOPLASTY Back to Search Results
Model Number 900SFC
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/02/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that 1 year 10 months post implant of this 28mm tricuspid annuloplasty ring, the device was explanted and replaced with a 29mm tricuspid bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported.
 
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Brand Name
RING TRI-AD 900SFC28
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key7070628
Report Number9612164-2017-01692
Device Sequence Number945108
Product Code KRH
UDI-Device Identifier00643169195356
UDI-Public00643169195356
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K093903
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/30/2017
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
Operator of Device Health Professional
Device Expiration Date08/31/2020
Device Model Number900SFC
Device Catalogue Number900SFC28
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2017
Initial Report FDA Received Date11/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age37 YR
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