MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RSAR-30
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Tamponade (2226); Pericardial Effusion (3271); Swelling/ Edema (4577)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.
Event or Problem Description
It was reported on (b)(6) 2021, a 30mm sjm rigid saddle ring was selected for implant.After the ring was implanted a leak/regurgitation was noted.The ring was explant and replaced with a 29mm epic stented porcine heart valve w/flexfit system on (b)(6) 2021.Post procedure nodal rhythm was noted interspersed with bigeminy was noted and no medical intervention was performed.On (b)(6) 2021, peripheral edema was reported and medication was administrated.On (b)(6) 2021, pleural fluid and a pericardial effusion was noted post surgery and diuretics were given and an acute pericardiocentesis was performed.Low hemoglobin was noted and it was due to a tamponade and the patient received vitamin k and cofact.The patient was reported to be in stable condition and is recovering.Additional information is pending.((b)(4)).
Additional Manufacturer Narrative
An event of leak/regurgitation after ring implant was 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 RIGID SADDLE RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 12341337
• Report Number: 3007113487-2021-00019
• Device Sequence Number: 4633528
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• 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: 2021
• Device Explanted 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): 09/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2026
• Device Model Number: RSAR-30
• Device Catalogue Number: RSAR-30
• Device Lot Number: 8013625
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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: 70 YR
• Patient Weight: 81