MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD EMBOLIC PROTECTION SYSTEM

Catalog Number UNK EMBOSHIELD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Thrombosis (2100)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Date of event estimated as (b)(6) 2013.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.Based on the case information, a conclusive cause for the reported patient effects of stroke and filter thrombosis, and the relationship to the product, if any, cannot be determined.The reported treatment with medication and hospitalization was likely due to case circumstances.The reported patient effects of stroke and filter thrombosis are listed in the emboshield nav6 instruction for use, as known possible adverse events that may be associated with embolic protection systems.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi number is unknown as the part and lot #s were not provided.Literature title: carotid artery stenting vs.Carotid endarterectomy: a comparative non-randomized study in two university hospitals.

Event Description

It was reported through a research article identifying the emboshield embolic protection device that may be related to a procedural stroke because of filter thrombosis prior to the stent being implanted.The patient was treated conservatively with a slow recovery process.Specific patient information is documented as unknown.Details are listed in the article, carotid artery stenting vs.Carotid endarterectomy: a comparative non-randomized study in two university hospitals.

• Brand Name: EMBOSHIELD 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: 11038003
• MDR Text Key: 222358070
• Report Number: 2024168-2020-10693
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK EMBOSHIELD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• 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 Outcome(s): Hospitalization; Required Intervention; Disability