MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD (WESTFORD, MA) SJM SGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number	SARP-30
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	11/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 30mm seguin annuloplasty ring was implanted as part of a mitral valve repair case.On post-operation echo, the patient had significant mitral regurgitation.On (b)(6) 2019, the ring was explanted and an unknown sized unknown mechanical heart valve was successfully implanted.No patient consequences were reported.
Additional Manufacturer Narrative
An event of mitral regurgitation was reported.The device met visual specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.
Additional Manufacturer Narrative
Additional information sections: b5, h2, h6, h10 an event of regurgitatoin was reported.The results of the investigation are inconclusive since the device was accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.If the device is made available for further examination, the investigation will be reopened.
Event or Problem Description
On (b)(6) 2019, a 30mm seguin annuloplasty ring was implanted as part of a mitral valve repair case.On post-operation echo, the patient had significant mitral regurgitation.On (b)(6) 2019, the ring was explanted and an unknown sized unknown mechanical heart valve was successfully implanted.No patient consequences were reported.

• Brand Name: SJM SGUIN SEMI-RIGID ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL CATD (WESTFORD, MA); 4 robbins drive; westford MA 01886
• MDR Report Key: 9504035
• Report Number: 2648612-2019-00112
• Device Sequence Number: 11063376
• Product Code: KRH
• UDI-Device Identifier: 05414734007511
• UDI-Public: 05414734007511
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020

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: 06/06/2022
• Device Model Number: SARP-30
• Device Catalogue Number: SARP-30
• Device Lot Number: 6492696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 02/18/2020; 10/27/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/09/2020; 11/11/2020
• 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