MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RIGID SADDLE RING
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Intracranial Hemorrhage (1891); Embolism/Embolus (4438)
Date of Event	09/26/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: crd_985 - arb pmcf patient site id: (b)(6).It was reported that on (b)(6) 2022, a 26mm rigid ring saddle was successfully implanted in a patient.The 29mm rigid ring saddle was sized using a ring sizer set.That same day the patient had a tricuspid annuloplasty performed.On (b)(6) 2021, the patient suffered an ischemic stroke and was admitted to the hospital.The ischemic stroke is believed to have been caused by a microemboli that formed during or after procedure.It was noted that the patient had been prescribed anticoagulants after the implant procedure.On (b)(6) 2021, a magnetic resonance imaging exam was performed and discovered new ganglion infarcts in the patient's brain.A computed tomography scan was also performed and discovered massive intracranial hemorrhaging as a result of the ischemic stroke.The patient had a craniotomy performed and required a transfusion.After the craniotomy it was noted that the patient had high brain pressure.The patient died on (b)(6) 2022, due to massive intercranial bleeding.No additional information was provided.
Additional Manufacturer Narrative
An event of ischemic stroke, massive intracranial hemorrhaging and patient death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM RIGID SADDLE 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: 15721393
• Report Number: 2135147-2022-01905
• Device Sequence Number: 15255140
• Product Code: KRH
• UDI-Device Identifier: 05414734009423
• UDI-Public: 05414734009423
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/12/2023

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: 08/04/2024
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-26
• Device Lot Number: 7121476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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: Death
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 93 KG