MAUDE Adverse Event Report: ABBOTT MEDICAL SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Catalog Number	SARP-28
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
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) 2024, a 28mm seguin annuloplasty ring was chosen for implantation.During the implantation, the ring dislodged from the holder handle and fell into the left ventricular cavity.The ring was surgically retrieved and a replacement non-abbott device was used to complete the mitral valve replacement.The patient remained hemodynamically stable throughout the procedure.The patient remained on cardiopulmonary bypass throughout.There was no clinically significant delay.
Additional Manufacturer Narrative
An event of ring dislodged from the holder handle was reported.The device was returned to abbott for analysis.The investigation found that the sewing thread on the ring was noted to be broken.There was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.There was no orifice damage observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Images received appeared to show the packed ring.The device damage might be due to handling during explant but cannot be confirmed.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2024, a 28mm seguin annuloplasty ring was chosen for implantation.During the implantation, the ring dislodged from the holder handle and fell into the left ventricular cavity.The ring was surgically retrieved and a replacement non-abbott device was used to complete the mitral valve replacement.The patient remained hemodynamically stable throughout the procedure.The patient remained on cardiopulmonary bypass throughout.There was no clinically significant delay.

• Brand Name: SJM SéGUIN SEMI-RIGID ANNULOPLASTY 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: 19035757
• Report Number: 2135147-2024-01496
• Device Sequence Number: 20863253
• Product Code: KRH
• UDI-Device Identifier: 05415067044792
• UDI-Public: (01)05415067044792(17)270714(10)9144919
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SARP-28
• Device Lot Number: 9144919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2023
• 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 Sex: Unknown