MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK XACT

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Transient Ischemic Attack (2109); Stenosis (2263); 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.Literature, 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, 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 x.Act css may be related to transient ischemic attack, cerebral vascular accident, myocardial infarction, access site complications, recurrent stenosis, and re-intervention (percutaneous and surgical).Although the above adverse events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the xact 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, d6a: 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 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, cerebral hemorrhage (cerebrovascular accident) and stenosis are listed in the xact carotid stent system information 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.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT 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: 12628867
• MDR Text Key: 276412522
• Report Number: 2024168-2021-09209
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• 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: 11/09/2021

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 XACT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• 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