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	Hematoma (1884)
Date of Event	05/19/2023
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
Crd_985 - arb pmcf.De4432 - (b)(4).It was reported that on (b)(6) 2023, a 32mm rigid saddle ring was implanted in a patient.On (b)(6) 2023, the patient returned to hospital after pectoral swelling induced by sneezing.Echocardiography showed hematoma in region under the surgical scar.The patient was treated with anticoagulation and did not required a blood transfusion.The device continues to work as intended.
Additional Manufacturer Narrative
An event of hemothorax was reported.The patient's medical history included paroxysmal atrial fibrillation.Information from the field indicated that the patient underwent a left atrial appendage closure, and patent foramen ovale (pfo) closure during the same surgery.The field indicated that reoperation was performed to remove the hematoma.There was no allegation of malfunction against the abbott device or procedure.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17135765
• Report Number: 2135147-2023-02595
• Device Sequence Number: 14435804
• 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: 2023
• 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): 08/15/2023

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: 8811369
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White