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

Model Number	ANNULOPLASTY RING
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/04/2022
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 35mm tailor annuloplasty ring was chosen for implant.At the end of the procedure, there was severe left ventricular (lv) dysfunction, which required high dose inotropes and intra-aortic balloon pump (iabp).There was slow inotrope weaning and need for noninvasive motion ventilation (nimv) due to hypoxia.On (b)(6) 2022, iabp was removed.It was noted that the patient had moderate depression of left ventricular function at baseline and that it was not unexpected after intervention.It was noted that the device was operating as expected.No other complications were noted.The patient was discharged in good clinical condition on (b)(6) 2022.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2022, a 35mm tailor annuloplasty ring was chosen for implant.At the end of the procedure, there was severe left ventricular (lv) dysfunction, which required high dose inotropes and intra-aortic balloon pump (iabp).There was slow inotrope weaning and need for noninvasive motion ventilation (nimv) due to hypoxia.On (b)(6) 2022, iabp was removed.It was noted that the patient had moderate depression of left ventricular function at baseline and that it was not unexpected after intervention.It was noted that the device was operating as expected.No other complications were noted.The patient was discharged in good clinical condition on (b)(6) 2022.Subsequent to the initially filed information, it was reported that on 17 april 2022, the patient's remote monitoring showed non-sustained ventricular tachycardia (nsvt), left bundle branch block (lbbb), right bundle branch block (rbbb).The patient was given anti-arrhythmic therapy via beta blockers.A permanent pacemaker was implanted on (b)(6) 2022.
Additional Manufacturer Narrative
An event of left ventricular dysfunction after the procedure and atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.G3 report source study was added.H6 health effect - clinical code 1721 was added.H6 health effect - clinical code 4624 was added.

• 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: 14392331
• Report Number: 2135147-2022-00269
• Device Sequence Number: 6714633
• Product Code: KRH
• UDI-Device Identifier: 05414734007726
• UDI-Public: 05414734007726
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K022363
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 04/18/2026
• Device Model Number: ANNULOPLASTY RING
• Device Catalogue Number: TARP-35
• Device Lot Number: 7934988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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: Hospitalization; Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White