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

Catalog Number UNK EMBOSHIELD NAV6

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

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

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average.Sex, ethnicity: majority.Date of event, implant date: estimated.Title: ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿.The device(s) are not returning.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi is unknown as the specific part/lot number(s) are unknown.The additional patient effects and abbott devices, along with device issues, referenced in the article, are captured under separate medwatch report numbers.

Event Description

The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿ evaluated the safety and performance of the rx acculink and x.Act carotid stent system (css) and the emboshield nav 6 and rx accunet embolic protection system (eps).It was reported through the pmcf report that the emboshield nav 6 may be related to transient ischemic attack, cerebral vascular accident, myocardial infarction, access site complication, 30-day death - stroke and myocardial infarction (dsmi).Additional data was obtained regarding the emboshield nav 6 in the lower limb indication.It was reported that the emboshield nav 6 may also be related to dissection, surgical embolization, embolic events, major and minor amputation, occlusion, dissection, perforation, distal embolization, thrombosis, renal complication, surgical and interventional re-treatment.Although the above adverse events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the emboshield nav 6 met the safety and performance criteria.This pmcf reports the abbott devices are similar to competitor devices and are within state-of-art.The abbott devices have comparable safety and performance issues when using versus competitor devices.The overall residual risk of device use is acceptable.Specific patient information is documented as unknown.Details are listed in the pmcf report titled ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿.

Manufacturer Narrative

A2: average.A3, a5b: majority.B3, estimated.D4: the udi# is unknown because the part and lot numbers were not provided.D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for evaluation.A review of the lot history record and similar incident query of the reported lot could not be conducted because the part and lot number were not provided.It should be noted that the reported patient effect(s) of myocardial infarction, transient ischemic attack, cerebrovascular accident, intimal dissection, embolism, occlusion, perforation, thrombosis and renal failure are listed in the emboshield nav 6 embolic protection system instructions for use as adverse events potentially associated with carotid stents and embolic protection systems.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D6a: this device is not implantable.

• 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: 12628896
• MDR Text Key: 276382649
• Report Number: 2024168-2021-09213
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK EMBOSHIELD NAV6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2021
• 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): Hospitalization; Disability; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White