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

Catalog Number 22443-19

Device Problems Retraction Problem (1536); Failure to Advance (2524)

Patient Problem Vasoconstriction (2126)

Event Date 02/04/2021

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 review of the complaint history identified no other incidents and/or complaints reported from this lot.Based on the information provided, the difficulty advancing the retrieval catheter and retrieving the filter was most likely due circumstances of the procedure.Based on the reported information, the difficulty advancing the retrieval catheter and retracting the filter was most likely due to interaction between the tip of the retrieval catheter and proximal end of the newly implanted stent.It may be possible that the stent was not fully apposed to the vessel wall or the proximal end of the stent was deployed within an angle of the vessel causing difficulty advancing the retrieval catheter to retrieve the filter.The reported vessel spasm and treatment with medication was due to case circumstances.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 performed to treat a lesion in the tortuous carotid artery.During the advancement of the rx retrieval catheter of an emboshield nav6 embolic protection system (eps), the distal tip interacted with the proximal part of the stent.The retrieval catheter was removed, and the physician tried to reshape the distal tip to put a small angle in order to avoid interacting with the stent wall.The retrieval catheter was re-inserted, but the tip interacted again with the stent.It was decided to pull on the filter and retract it into the catheter.The filter was able to be retrieved into the retrieval catheter without issue to the filter or to the stent.Reportedly, the physician observed spasm at the artery above the stent.An unspecified medication was administered and the spasm was resolved some minutes after.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure.No additional 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: 11338513
• MDR Text Key: 232223819
• Report Number: 2024168-2021-01262
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 22443-19
• Device Lot Number: 0112361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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