MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RIGID SADDLE RING
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/17/2022
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 - 478 (r744179301).It was reported that on (b)(6) 2022 that a 34mm rigid saddle ring was implanted.On (b)(6) 2022 an x-ray was performed and revealed pneumothorax.The patient did not experience any clinical symptoms.On (b)(6) 2022 drainage was performed to resolve the event.The patient was discharged at the time of report.The direct cause of the pneumothorax is unknown, but there is no allegation of malfunction against the 34mm rigid saddle ring or procedure.
Additional Manufacturer Narrative
An event of pneumothorax was reported.A returned device assessment could not be performed as the was not returned for analysis.The patient's medical history included atrial fibrillation, anemia, hypercholesterolemia, and kidney disease.Information from the field indicated that pneumothorax is regarded as known complication after thoracic surgery.There was no allegation of malfunction against the abbott device.The physician believed the reported event could have been an interventional complication.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): 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: 16704904
• Report Number: 2135147-2023-01548
• Device Sequence Number: 3667081
• Product Code: KRH
• UDI-Device Identifier: 05415067044730
• UDI-Public: 05415067044730
• 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: 2022
• 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): 06/19/2023

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 Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-34
• Device Lot Number: 8662807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White