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

Model Number	RSAR-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	12/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 rigid saddle ring was implanted.On (b)(6) 2021, the patient was experiencing sudden thoracic swelling.A ct was performed and a thorax, subcutaneous and intrathoracic hematoma was noted.A stent was implanted on (b)(6) 2021 however, swelling was notably more.Another ct was performed an showed an increase of intrathoracic hematoma and was surgically removed on (b)(6) 2022.The patient was reported to be in stable condition post procedure.On (b)(6) 2022, a chest x-ray was performed a limited pneumothorax was noted.A chest drain was inserted.Latera follow-up chest x-ray was performed and no pneumothorax was noted.The patient was reported to be in stable condition.((b)(4)).
Additional Manufacturer Narrative
An event of thoracic swelling and hematoma was reported.A more comprehensive 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.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13258699
• Report Number: 3007113487-2022-00022
• Device Sequence Number: 16534558
• Product Code: KRH
• UDI-Device Identifier: 05414734009430
• UDI-Public: 05414734009430
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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 Model Number: RSAR-28
• Device Catalogue Number: RSAR-28
• Device Lot Number: 8178538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 70 KG