MAUDE Adverse Event Report: ABBOTT MEDICAL Tailory Flexible Annuloplasty Band; Ring, Annuloplasty

Model Number	TARP-27
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hemolysis (1886)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.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) 2026, a 27mm tailor flexible annuloplasty ring was implanted in the patient.Postoperatively, the patient had persistent hematuria and hemoglobin (hb) remained low after blood transfusion.An unexplained hemolysis occurred.A reoperation was performed on (b)(6) 2026, the ring got explanted and a new 27mm sjm masters series mechanical heart valve was implanted.The procedure was finished successfully without patient consequence.The patient remained stable throughout the procedure and is currently stable.
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm tailor flexible annuloplasty ring was implanted in the patient.Postoperatively, the patient had persistent hematuria and hemoglobin (hb) remained low after blood transfusion.An unexplained hemolysis occurred.A reoperation was performed on (b)(6) 2026, the ring got explanted and a new 27mm sjm masters series mechanical heart valve was implanted.The procedure was finished successfully without patient consequence.The patient remained stable throughout the procedure and is currently stable.
Additional Manufacturer Narrative
An event of persistent hematuria, low hemoglobin after blood transfusion and hemolysis was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was also 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 patient effects could not be conclusively determined.The reported medical intervention included blood transfusion to address the patient¿s condition.Surgical intervention involved a reoperation to explant the device.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): Abbott Medical Reg# 2648612; lot 20 b st caguas; caguas 00725 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 24912670
• Report Number: 2135147-2026-02493
• Device Sequence Number: 15731246
• Product Code: KRH
• UDI-Device Identifier: 05415067044419
• UDI-Public: (01)05415067044419(17)300604
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 10/02/2026

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: TARP-27
• Device Catalogue Number: TARP-27
• Device Lot Number: 10896530
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 06/10/2026; 09/09/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/18/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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