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

Catalog Number PRT-NG-35

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

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/06/2022

Event Type  Injury  

Event Description

Clinical study patient id: (b)(6).It was reported that on (b)(6) 2022, a 35mm portico ng/navitor titan valve was chosen for implant using a flexnav delivery system.A pre-implant valvuloplasty was performed once with a 24mm non-abbott balloon.The access route for the delivery system was the left transfemoral artery.The valve was re-sheathed once before being successfully implanted.A non-abbott guidewire was used to deploy the valve.A post-implant balloon valvuloplasty was not performed.The distance from the non-coronary cusp (ncc) to the ventricular end of the frame was 5.5 mm.The distance from the left coronary cusp (lcc) to the ventricular end of the frame was 4.3 mm.During procedure, the patient's highest activated clotting time (act) was 329 seconds.Post procedure later that day, a left bundle branch block (lbbb) was seen on electrocardiogram (ecg).The patient received a permanent pacemaker.On (b)(6) 2022, the patient developed shortness of breath, tachypnea, and pulmonary edema.Patient was administered diuretic lasix for acute heart failure.On (b)(6) 2022, the patient was discharged.On (b)(6) 2022, the patient presented to the emergency department with shortness of breath.A chest x-ray was performed.The patient status was reported as unknown.

Manufacturer Narrative

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

Manufacturer Narrative

An event of permanent pacemaker implantation following a left bundle branch block was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated that the patient's past medical history included aortic balloon valvuloplasty, atrial fibrillation, sinus bradycardia, and hypertension.The valve was also implanted with 5.5 mm depth from the non-coronary cusp and 4.3 mm from the left coronary cusp deeper than the optimal 3mm depth.The cause of the reported event could not be conclusively determined but could have been caused by a combination of the implant depth valve and the patient's medical history.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note per the instructions for use : "to minimize the likelihood of permanent pacemaker implantation (ppi): a) maintain implant depth of 3mm, and b) limit manipulations across the lvot.".

Event Description

N/a.

• 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: 15503471
• MDR Text Key: 301241938
• Report Number: 2135147-2022-01403
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-35
• Device Lot Number: 8195621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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
• Treatment: FLEXNAV DELIVERY SYSTEM, FN-DS-LG-IDE, 19408409
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Hispanic