MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22443-19

Device Problems Material Separation (1562); Stretched (1601); Difficult to Advance (2920); Material Too Soft/Flexible (4007)

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

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous internal carotid artery that is 75% stenosed.The emboshield nav6 embolic protection system (eps) as attempted to be advanced across the lesion; however the barewire stopped giving any tactile feedback and stop advancing.Therefore, the eps was attempted to be removed; however, the eps barewire stretched (tip and coils) and separated near the groin.The tip of the wire was snared out and new emboshield nav6 was used to successfully complete the procedure.There were no adverse patient sequela and no clinically significant delay in the procedure.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported, stretching and tip separation was confirmed.The difficulty advancing and lack of tactile feedback was not confirmed due to the condition of the returned unit.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.The investigation determined that the reported inadequate tactile feedback, difficulty advancing, stretched tip coils, and material separation resulting in unexpected medical intervention to snare the separated portion of the wire were likely related to procedural circumstances.Based on the reported information, it is likely that during the attempt to advance the barewire into the 75% stenosed lesion, the tip of the barewire became lodged/stuck and/or prolapsed within the artery resulting in stretching of the tip coils and ultimately separation during removal.The reported unexpected medical intervention to remove the separated tip was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15704673
• MDR Text Key: 302760331
• Report Number: 2024168-2022-11135
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141678
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 2030361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2022
• 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): Required Intervention