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 Code	Heart Block (4444)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical study patient id: (b)(6), crd 985 arb pmcf stud, (b)(4).It was reported that on (b)(6) 2022, a 30mm rigid saddle ring was successfully implanted.Concomitant cardiac procedures included left atrial appendage closure, thoracic aorta repair, aortic valve replacement, and cryoablation.On (b)(6) 2022, the patient was evaluated with an electrocardiogram (ecg) for 24 hours and was noted to have a third-degree atrioventricular (av) block.On (b)(6) 2022, a pacemaker was implanted to resolve this event, and the patient was discharged.The cause of the av block was unknown since there were several concomitant procedures performed.There was no allegation of malfunction against the abbott device.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.Na.
Additional Manufacturer Narrative
An event of third-degree atrioventricular (av) block 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.
Event or Problem Description
Subsequent to the initially filed information, it was reported that on (b)(6) 2022, an ekg showed worsening ejection fraction (ef).After consultation with cardiology, a percutaneous coronary intervention (pci) was decided.On (b)(6) 2022, a pci was performed and a drug-eluting stent (des) was implanted.

• 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: 14251420
• Report Number: 2135147-2022-00230
• Device Sequence Number: 14674244
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-30
• Device Lot Number: 8310413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG