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

Catalog Number RSAR-32

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 11/18/2022

Event Type  Injury  

Event 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.

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
• 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: 17740792
• MDR Text Key: 323331789
• Report Number: 2135147-2023-03968
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: RSAR-32
• Device Lot Number: 8474174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 100 KG