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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	02/16/2022
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
It was reported that on (b)(6) 2022, a 34mm rigid saddle ring was implanted.An atrial septal defect was also closed during the procedure.After the procedure, there was major bleeding.Surgical intervention was required to remove a hematoma.
Additional Manufacturer Narrative
An event of bleeding after the implant procedure was reported.The device was reported to be functioning as intended and that there was no performance issues with the device.A returned device 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.Information from the field indicated that the bleeding was caused by thrombocytopenia.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the device remains successfully implanted and is still working as intended.There were no performance issues with the abbott device.The bleeding was noted on the same day within a few hours of the procedure and was caused by thrombocytopenia.The bleeding was diffusely in the thoracic region with no localization.The patient's activated clotting time (act) levels were unknown.Heparin was administered during the procedure.Prior to procedure, the patient's international normalized ratio (inr) was 1.3, and post-procedure the inr was 1.0.No blood transfusion was required.
Additional Manufacturer Narrative
An event of bleeding after the implant procedure was reported.Also reported was pneumothorax 3 days after the procedure.The device was reported to be functioning as intended and that there was no performance issues with the device.A returned device 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.Information from the field indicated that the bleeding was caused by thrombocytopenia.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was reported that on (b)(6) 2022, the patient experienced a pneumothorax.The pneumothorax was drained, and the event was resolved on (b)(6) 2022.

• 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: 14459701
• Report Number: 2135147-2022-00302
• Device Sequence Number: 11936948
• Product Code: KRH
• UDI-Device Identifier: 05414734009461
• UDI-Public: 05414734009461
• 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,Followup
• Report Date (Section B): 02/02/2023

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 Expiration Date: 10/18/2025
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-34
• Device Lot Number: 7707022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 07/15/2022; 01/30/2023
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/27/2022; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White