MAUDE Adverse Event Report: ABBOTT MEDICAL SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number	SARP-32
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 30mm semi-rigid saddle ring(b)(4) was implanted in the mitral position.After the ring was implanted and during the saline test, it was observed that there was improper coaptation.The user alleged that this failure was due to the severe calcification of the annulus and patient anatomy.It was noted that there were no allegations of malfunction against the semi-rigid saddle ring.The ring was replaced with a 32mm semi-rigid saddle ring (b)(4) intraoperatively.On (b)(6) 2022, the 32mm ring was explanted since there was not much improvement with respect to regurgitation.The patient was suffering from dyspnea after coming off from ventilation support in the intensive care unit (icu).The user alleged that this failure was also due to severe calcification of the annulus and patient anatomy as well.There were no allegations of malfunction against the saddle ring.It was noted that during the procedure, they had no other suitable sized ring available so they used the 32mm semi-rigid saddle ring.The device was replaced with a non-abbott mechanical valve.It was noted that the patient remained hemodynamically stable throughout both procedures.The patient is reportedly stable.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of incomplete coaptation of the native valve after the ring was implanted was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that there was no allegation of malfunction of the ring.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14081828
• Report Number: 2135147-2022-00162
• Device Sequence Number: 16668199
• Product Code: KRH
• UDI-Device Identifier: 05414734007528
• UDI-Public: 05414734007528
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: SARP-32
• Device Catalogue Number: SARP-32
• Device Lot Number: 6401463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 45 KG