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

Catalog Number	RSAR-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_985 - arb pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 32mm rigid saddle ring was implanted during a mitral valve repair.There were no intraprocedural adverse events or device deficiencies.On (b)(6) 2022, the patient returned during follow up with complaints of difficulty breathing.The patient was diagnosed with pleurisy and prescribed paracetamol and oxycodon.There were no device deficiencies reported.The patient status was stable.
Additional Manufacturer Narrative
An event of pleurisy was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The patient has a medical history of hypercholesterolemia.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There was no allegation of malfunction against the abbott device.Based on the information received, the root cause of the reported event 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: 17740792
• Report Number: 2135147-2023-03968
• Device Sequence Number: 6736428
• Product Code: KRH
• UDI-Device Identifier: 05415067044716
• UDI-Public: 05415067044716
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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 Catalogue Number: RSAR-32
• Device Lot Number: 8474174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 100 KG