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

Model Number	SARP-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pneumothorax (2012)
Date of Event	06/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical study patient id: (b)(6).It was reported that on (b)(6) 2022, a 28 mm seguin annuloplasty ring was successfully implanted.On (b)(6) 2022, it was reported that the patient experienced cardiac arrest due to massive pneumothorax and subcutaneous emphysema and was treated with adrenaline and heart massage for 10mins before return of spontaneous circulation (rosc) occurred.The patient was intubated and brought to the intensive care unit for two days.Patient was extenuated, without neurological defect.A computed tomography (ct) scan showed right pneumothorax and was drained.No valvular problem noted on echocardiogram and there was good contractility and function of the ventricles.No pericardial effusion was observed, and the device was working as intended.The patient was reported to be in stable condition.
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 cardiac arrest was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The ring was reported to be functioning as intended.Information from the field indicated that a pneumothorax and subcutaneous emphysema caused the cardiac arrest.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15540276
• Report Number: 2135147-2022-01482
• Device Sequence Number: 20603914
• Product Code: KRH
• UDI-Device Identifier: 05414734007559
• UDI-Public: 05414734007559
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 02/04/2026
• Device Model Number: SARP-38
• Device Catalogue Number: SARP-38
• Device Lot Number: 8330490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White