MAUDE Adverse Event Report: ABBOTT MEDICAL TAILORY FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Catalog Number	TAB-29
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 29mm tailor flexible annuloplasty band was chosen for a mitral valve plasty (mvp) procedure.The device was implanted.When removing cardiopulmonary bypass, systolic anterior movement (sam) was observed in echocardiography.The band was explanted, and a 36mm non-abbott device was implanted before closing patient's chest.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of systolic anterior movement was reported when the patient was taken off cardiopulmonary bypass, requiring putting the patient back on cardiopulmonary bypass and explanting the device.A returned device assessment could not be performed as the device 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.Based on the information received, the cause of the reported incident 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 29mm tailor flexible annuloplasty band was chosen for a mitral valve plasty (mvp) procedure.The device was implanted.When removing cardiopulmonary bypass, systolic anterior movement (sam) was observed in echocardiography.The band was explanted, and a 36mm non-abbott device was implanted before closing patient's chest.The patient was reported stable.
Additional Manufacturer Narrative
An event of systolic anterior movement was reported when the patient was taken off cardiopulmonary bypass, requiring putting the patient back on cardiopulmonary bypass and explanting the device.A returned device assessment could not be performed as the device 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.Systolic anterior motion is a possible outcome of the procedure per the tailor¿ annuloplasty band instructions for use.Adverse events listed in ifu are not necessarily considered to be related to poor device quality.Based on the information received, the cause of the reported incident could not be conclusively determined, and the relationship to the device implantation was not identified.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: TAILORY FLEXIBLE ANNULOPLASTY BAND
• 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: 19241501
• Report Number: 2135147-2024-01980
• Device Sequence Number: 20685814
• Product Code: KRH
• UDI-Device Identifier: 05415067044556
• UDI-Public: (01)05415067044556(17)280914(10)9244382
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022363
• 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,Followup
• Report Date (Section B): 07/16/2024

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: TAB-29
• Device Lot Number: 9244382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 07/11/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2023
• 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