MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS

Model Number FNAV-DS-SM

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a small flexnav delivery system was selected to implant a device.During the procedure, as the physician advanced the delivery system, some resistance was observed and the delivery system was immediately removed.A kink was observed in the end of the valve capsule.The physician alleged that the kink was caused by an incorrectly placed proglide on the guidewire which caught on the device whilst he inserted it in the delivery system.Prior to the procedure, there was no damage done to the product box or the device itself and the device no damaged due to handling during preparation was reported.The device was exchanged with a new flexnav delivery system that deployed the valve successfully with no further issues.There was prolonged procedure time and the patient needed an extra dose of contrast and radiation.The patient also had some vascular complications at the end of the case, no treatment was provided.The physician allege that a small femoral anatomy along with the proglide caused the issue.The patient remain hemodynamically stable throughout the procedure,.

Manufacturer Narrative

An event of some resistance noted when advancing the delivery system and a kink in valve capsule was reported.A returned device assessment could not be performed as the device 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 incident could not be conclusively determined.Na.

• Brand Name: FLEXNAV DS
• Type of Device: FLEXNAV DS
• 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: 15846851
• MDR Text Key: 304174801
• Report Number: 2135147-2022-02180
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: 05415067031372
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 8409496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 67 KG