MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY BAND; RING, ANNULOPLASTY

Model Number	800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this annuloplasty ring was implanted and explanted on the same day.The reason for explant is unknown.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information indicates that this annuloplasty ring was successfully implanted in the tricuspid position.There was no problem with the product.The registration form incorrectly listed the product as implanted in the mitral position.The device remains implanted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• MDR Report Key: 6540443
• Report Number: 2025587-2017-00727
• Device Sequence Number: 10766416
• Product Code: KRH
• UDI-Device Identifier: 00643169182141
• UDI-Public: 00643169182141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2017

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 Date: 08/31/2020
• Device Model Number: 800
• Device Catalogue Number: 800SC36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: Not provided; 09/25/2017; 09/25/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 05/11/2017; 09/26/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR