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

Model Number ANNULOPLASTY RING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 02/24/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2023, a 35mm tailor flexible annuloplasty ring was successfully implanted.Two days post procedure on (b)(6) 2023, the patient presented with right hemiparesis.Magnetic resonance imaging (mri) was performed and showed semi-recent left cerebellar sequela and 2 small recent ischemic lesions (one was left superior frontal, and one was left para-central).Anticoagulants and antiplatelet medications were administered.The patient was also sent to post stroke rehabilitation and the stroke symptoms were still ongoing at the last report.

Event Description

Clinical information: (b)(6) - arb pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 35mm tailor flexible annuloplasty ring was successfully implanted.Two days post procedure on (b)(6) 2023, the patient presented with right hemiparesis.Magnetic resonance imaging (mri) was performed and showed semi-recent left cerebellar sequela and 2 small recent ischemic lesions (one was left superior frontal, and one was left para-central).Anticoagulants and antiplatelet medications were administered.The patient was also sent to post stroke rehabilitation and the stroke symptoms were still ongoing at the last report.

Manufacturer Narrative

An event of right hemiparesis, semi-recent left cerebellar sequela, and 2 small recent ischemic lesions was reported.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.Based on the information received, the reported event is most likely procedure -related since a stroke is a known potential adverse event associated with performing open heart surgical procedures, including valve repair using an annuloplasty ring.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: TAILORY FLEXIBLE ANNULOPLASTY BAND
• Type of Device: 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: 17214101
• MDR Text Key: 317989514
• Report Number: 2135147-2023-02821
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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
• Device Operator: Health Professional
• Device Model Number: ANNULOPLASTY RING
• Device Catalogue Number: TARP-35
• Device Lot Number: 8757401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG