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

Catalog Number UNK EMBOSHIELD NAV6

Device Problem Difficult to Advance (2920)

Patient Problems Bradycardia (1751); Pain (1994); Restenosis (4576)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information provided, the difficulty advancing the retrieval catheter was the result of interaction with the deployed stent.The additional treatment 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.Article, titled: drug-eluting balloon angioplasty for in-stent restenosis following carotid artery stent placement.

Event Description

It was reported that the procedure was to treat a left internal carotid artery.A non-abbott guide wire was advanced and placed and a emobshield nav6 embolic protection system (eps) was deployed.A non-abbott balloon catheter was advanced over a hi-torque pilot 200 guide wire.The balloon was inflated to 8 atmospheres (atm); however, was reduced to 6 atm as the patient began to experience local pain and bradycardia.One milligram of atropine was provided intravenously.The balloon was deflated and retracted a little and second inflation was performed at 8 atm.The eps removal was noted to be complicated as there was resistance during advancement of the retrieval catheter through the unspecified deployed stent requiring to advance a non-abbott 6-f guide sheath to remove the filter successfully.There was no clinically significant delay reported.Serial doppler ultrasound was performed at day 1, 1 month, and 6 months post procedure and revealed a decrease in peak systolic velocity and a consistent 20-49% restenosis.Details are listed in the article, titled: drug-eluting balloon angioplasty for in-stent restenosis following carotid artery stent placement.

• 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: 11395084
• MDR Text Key: 234185875
• Report Number: 2024168-2021-01562
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK EMBOSHIELD NAV6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• 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): Required Intervention