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

Catalog Number RSAR-32

Device Problem Material Separation (1562)

Patient Problem Stroke/CVA (1770)

Event Date 01/15/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 320211086
• Report Number: 2135147-2023-03359
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSAR-32
• Device Lot Number: 7494107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 89 KG