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

Catalog Number UNK EMBOSHIELD NAV6

Device Problems Difficult to Insert (1316); Activation Failure (3270)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Renal Failure (2041); Transient Ischemic Attack (2109); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Respiratory Failure (2484); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Age - average.Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.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 part and lot numbers were not reported.The reported patient effects of stroke, transient ischemic attack (tia), myocardial infarction (mi), unspecified tissue injury, respiratory failure, renal failure, thrombosis/thrombus, obstruction/occlusion, embolism/embolus, vascular dissection, and perforation of vessels are listed in the emboshield nav6 instruction for use (ifu), as known possible adverse events potentially associated with carotid stents and embolic protection devices based on the information reported through the pmcf report, a definitive cause for the reported difficulty to insert and activation failure could not be determined.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The patient deaths and the other adverse events reported in the pmcf are filed under separate medwatch report numbers.Attachment: title ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿na.

Event Description

It was reported through the post market clinical follow-up (pmcf) report, that the emboshield nav6 embolic protection device may be related to the adverse patient effects of death, myocardial infarction, access site complications, pulmonary complications, renal complications, transient ischemic attack, stroke, thrombosis, occlusion, embolization, dissection, perforation, intervention, medication administration, amputation / surgery and re-hospitalization and device issues of unable to insert and unsuccessful placement.Details are listed in the attached article, titled post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems.

• 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: 15643483
• MDR Text Key: 302162772
• Report Number: 2024168-2022-10882
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: 09/29/2022
• 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): Disability; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male