MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DELIVERY SYSTEM; Aortic valve, prosthesis, percutaneously delivered

Catalog Number UNK FLEXNAV DS

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Vascular Dissection (3160)

Event Date 09/01/2017

Event Type  Injury  

Event Description

The article, "femoral vessel complications after transfemoral tavr¿a contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves", was reviewed.The article presented a prospective, single center study that investigated the incidence and risk factors of femoral vessel complications in a modern transcatheter aortic valve replacement (tavr) collective using postinterventional sonography.Devices included in this study were sapien s3/s3 ultra, evolut/pro/pro plus, portico/navitor, accurate/neo, allegra, and jenavalve.The article concluded the incidence of postinterventional femoral artery stenosis following transfemoral-tavr was higher than expected with a number of used closure devices and female sex being independent risk factors.Considering the continuous advance of tavr in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.[the primary and corresponding author was (b)(6).

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.Summarized patient outcomes/complications of flexnav ds were reported in a research article in a subject population with multiple co-morbidities including arterial hypertension, diabetes, dyslipidemia, peripheral artery disease, chronic lung disease, smoking history, dialysis.Some of the complications reported were bleeding, vascular stenosis, pseudoaneurysm, dissection, atrio-venous fistula, hematoma, surgical intervention, hospitalization.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Based on available information, root causes for the reported events could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: FLEXNAV DELIVERY SYSTEM
• Type of Device: Aortic valve, prosthesis, percutaneously delivered
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18445349
• MDR Text Key: 331914368
• Report Number: 2135147-2024-00058
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2024

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 Catalogue Number: UNK FLEXNAV DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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