MAUDE Adverse Event Report: ABBOTT VASCULAR ACCUNET EMBOLIC PROTECTION SYSTEM

Catalog Number UNK RX ACCUNET

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2012

Event Type  malfunction  

Manufacturer Narrative

Date of event: date is estimated.The additional devices referenced are being filed under separate medwatch report #s.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 in the research article, a conclusive cause for the difficulty withdrawing the epd could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Attachment: article title: predictive values of carotid high-resolution magnetic resonance imaging for large embolus shedding in carotid artery stenting.

Event Description

It was reported through a research article identifying acculink that may be related to the following: patient hyperperfusion, intracranial hemorrhage, bradycardia, hypotension, headache, neurological deficit, medication, revascularization, and rehospitalization.Additionally, it was identified that accunet and emboshield nav6 may be related to the following: difficulty withdrawing the systems.This article summarizes clinical outcomes of 195 patients that were treated with acculink stents and accunet/emboshield nav6 embolic protection systems.Specific patient information is documented as unknown.Details are listed in the attached article, titled "predictive values of carotid high-resolution magnetic resonance imaging for large embolus shedding in carotid artery stenting.".

• Brand Name: ACCUNET 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: 11124644
• MDR Text Key: 225335601
• Report Number: 2024168-2021-00130
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081549
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX ACCUNET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• 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 Age: 64 YR