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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION SIMULUS SEMI-RIGID ANNULOPASTY BAND RING, ANNULOPLASTY
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MEDTRONIC HEART VALVE DIVISION SIMULUS SEMI-RIGID ANNULOPASTY BAND RING, ANNULOPLASTY Back to Search Results
Model Number 800SC36
Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative

No product was returned. 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 Description

Medtronic received information that this 36mm mitral annuloplasty band was implanted and explanted during the same procedure for unknown reasons. No additional adverse patient effects were reported.  .

 
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Brand NameSIMULUS SEMI-RIGID ANNULOPASTY BAND
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9208403
MDR Text Key163025935
Report Number2025587-2019-03190
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number800SC36
Device Catalogue Number800SC36
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 Received11/21/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/18/2019 Patient Sequence Number: 1
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