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

Model Number	SARP-34
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/28/2021
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 34mm sjm sã©guin semi-rigid annuloplasty ring was implanted.On 28 (b)(6) 2021, a routine chest x-ray was performed and noted a pneumothorax.On (b)(6) 2021, the pneumothorax was drained.It is thought that the pneumothorax was due to a minimal lesion on lung that occurred during the procedure prep while performing a mini thoracotomy.The patient was reported to be in stable condition.((b)(4)).
Additional Manufacturer Narrative
Correction: upon review, the sjm sã©guin semi-rigid annuloplasty ring should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

• Brand Name: SJM SGUIN SEMI-RIGID ANNULOPLASTY 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: 12468411
• Report Number: 3007113487-2021-00039
• Device Sequence Number: 14405898
• Product Code: KRH
• UDI-Device Identifier: 05414734007535
• UDI-Public: 05414734007535
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/24/2021

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: 03/05/2024
• Device Model Number: SARP-34
• Device Catalogue Number: SARP-34
• Device Lot Number: 7554610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 70