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

Catalog Number XRX03009T

Device Problem Material Separation (1562)

Patient Problem Stroke/CVA (1770)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on (b)(6) 2020 an xact stent was implanted in the heavily calcified right internal carotid artery.After the stent was deployed, part of the stent did not expand all the way, creating what looked like a dog bone.After post dilatation, the stent expansion was improved.On approximately (b)(6) 2021, the patient experienced a stroke.Angiography noted that the stent had separated in 2 pieces.There are no plans to treat.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The reported patient effect of a stroke or other neurological complications is a known potential patient effect as listed in the xact carotid stent system electronic instructions for use (ifu).Additionally, a medical review of the event was performed, and a probable cause for the stroke could not be determined as there were no provided images for this event.The investigation was unable to determine a conclusive cause for the reported difficulties.It is possible that anatomical conditions contributed to the reported stent fracture appearing as a (dog bone) but was later noted as a separation.The xact stent was subjected to stress/ fatigue or repetitive movement within the heavily calcified right internal carotid artery.The reported patient effect of a cerebrovascular accident 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.

Event Description

Subsequent to the previous reports, additional information was received: the patient had a confirmed stroke.The patient was hospitalized.The stent explanted and sent for histopathology which showed platelet aggregation.No additional information was provided.

Manufacturer Narrative

D6b: explant date - estimated.The reported treatment and hospitalization are likely related procedural circumstances.

• 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
• MDR Report Key: 11392759
• MDR Text Key: 234019201
• Report Number: 2024168-2021-01546
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: XRX03009T
• Device Lot Number: 9012361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability