MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM SGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number	SARP-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Thrombocytopenia (4431)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported on (b)(6) 2021, a 28mm sjm sã©guin semi-rigid annuloplasty ring was implanted.During procedure hypofibrinogenemia, thrombocytomia and anemia leading to bleeding.The patient received a platelet transfusion and medications.The patient has a history of the following; atrial fibrillation, coronary artery disease, non-ischemic cardiomyopathy.Other medical conditions: hypertension, hypercholesterolemia, thrombosis, peripheral vascular disease, kidney and liver disease.The patient is alive and since has been discharged from the hospital.(b)(4).
Additional Manufacturer Narrative
An events of hypofibrinogenemia, thrombocythemia and anemia that lead to bleeding were reported.A more comprehensive assessment could not be performed as the device 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.

• Brand Name: SJM SGUIN SEMI-RIGID ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 12372851
• Report Number: 2648612-2021-00090
• Device Sequence Number: 1206525
• Product Code: KRH
• UDI-Device Identifier: 05414734007504
• UDI-Public: 05414734007504
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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 Expiration Date: 04/06/2024
• Device Model Number: SARP-28
• Device Catalogue Number: SARP-28
• Device Lot Number: 7487417
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 79