MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Catalog Number NVTR-27

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

An event of hypotension, ventricular tachycardia, and right sided embolic stroke was reported.The field indicated that the stroke was caused by a calcium fragment, and the clot was removed.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 cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that a 27mm navitor valve was selected for an emergency valve in valve procedure on (b)(6) 2022 due to a failing non-abbott bioprosthetic valve.The implant depth was 3mm ncc 4mm lcc and there was no calcification extending beneath aortic annular plane in the interventricular septum.The valve was successfully implanted during the first deployment attempt.It was noted that the patient was very unstable following induction of anesthesia, with hypotension and non-sustained ventricular tachycardia runs.Patient stabilized once the 27mm navitor valve was implanted.Once the patient had woken up from anesthesia and it was noted that the they weren't responding to commands.It was assumed that the patient had a stroke and was transferred to receive a brain computed tomography (ct) scan immediately.It revealed a right sided embolic stroke causing left side hemiplegia with dysphasia.Clot retrieval was performed immediately and the clot was removed.Patient has made a complete recovery from their stroke and has been discharged home.It was believed that the stroke was caused by calcium fragment.The 27mm navitor valve was working as intended.The patient's activated clotting time was noted as 290 seconds.

Event Description

N/a.

Manufacturer Narrative

An event of hypotension, ventricular tachycardia, and right sided embolic stroke was reported.The field indicated that the stroke was caused by a calcium fragment, and the clot was removed.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 cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 2993 removed and code 1494 added.

• Brand Name: NAVITOR
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15109036
• MDR Text Key: 296654297
• Report Number: 2135147-2022-00578
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8274831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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): Required Intervention
• Patient Sex: Male