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

Catalog Number	RSAR-32
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/15/2023
Type of Reportable Event	Serious Injury
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 study id: (b)(6).It was reported that on (b)(6) 2021, a 32mm rigid saddle ring was successfully implanted.The patient was discharged.On (b)(6) 2023, the patient was experienced paraphasia and temporary paraplegia of the right arm.The patient was admitted with neurological symptoms.On (b)(6) 2023, a computerized tomography (ct) and magnetic resonance imaging (mri) that the patient experienced an ischemic stroke.Apixaban was administered.It was confirmed via transesophageal echocardiogram (tee) was performed and showed that the surgical suture was loosening.It was believed that the stroke was caused by a thrombus on the surgical suture, but imaging of thrombus was not confirmed.Slight aphasia was still present at the time of the last report.The patient was reported as stable at home.
Additional Manufacturer Narrative
An event of ischemic stroke and loosening of surgical suture was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.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.
Event or Problem Description
Clinical information: (b)(6) patient study id: (b)(6).It was reported that on (b)(6) 2021, a 32mm rigid saddle ring was successfully implanted.The patient was discharged.On (b)(6) 2023, the patient was experienced paraphasia and temporary paraplegia of the right arm.The patient was admitted with neurological symptoms.On (b)(6) 2023, a computerized tomography (ct) was performed.On (b)(6) 2023, a magnetic resonance imaging (mri) showed that the patient experienced an ischemic stroke.On (b)(6) 2023, it was confirmed via transesophageal echocardiogram (tee) was performed and showed that the surgical suture was loosening.It was believed that the stroke was caused by a thrombus on the surgical suture, but there was no imaging of a thrombus to confirm this theory.On (b)(6) 2023, patient was started on apixaban.Slight aphasia was still present at the time of the last report.The patient was reported as stable at home.

• 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: 17437712
• Report Number: 2135147-2023-03359
• Device Sequence Number: 15155619
• Product Code: KRH
• UDI-Device Identifier: 05415067044716
• UDI-Public: 05415067044716
• 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): 09/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2025
• Device Catalogue Number: RSAR-32
• Device Lot Number: 7494107
• 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: 07/09/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• 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: Life Threatening; Hospitalization; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 89 KG