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

Catalog Number 22443-19

Device Problem Difficult to Remove (1528)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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 query of the complaint handling database for the reported lot revealed no other similar complaints reported from this lot.Based on the information provided, a definitive cause for the difficulty removing the delivery catheter after successful filter deployment could not be determined.It may be possible that the delivery catheter and barewire were kinked or bent preventing the ability to remove the delivery catheter from the barewire; however, without having the product to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the left common carotid artery with moderate calcification and heavy tortuosity.The large emboshield nav6 embolic protection system (eps) was advanced to the it's intended location and the filter was deployed; however while removing the delivery catheter the filter was noted to be coming back with the delivery catheter.The physician unsuccessfully attempted 2-3 times to remove the delivery catheter without the filter.Therefore, the filter, delivery catheter and the guide catheter were removed as a single unit.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another emboshield nav6 followed by pre-dilatation with a non-abbott balloon and implantation of an xact stent were used to complete the procedure.No addtional information was provided.

• 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: 15921165
• MDR Text Key: 306828945
• Report Number: 2024168-2022-12241
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 2060761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG