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

Model Number RIGID SADDLE RING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 312933735
• Report Number: 2135147-2023-01548
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White