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

Model Number 82090-01

Device Problem Material Separation (1562)

Patient Problem Stenosis (2263)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of stenosis and hospitalization are a known potential patient effects as listed in the xact carotid stent system electronic instructions for use (ifu).Cine images were reviewed by an abbott clinician noting that the associated images confirm the incident report/complaint of a fractured xact stent although a cause cannot be determined from the images.Factors that may contribute to a stent fracture include, but are not limited to, bending, axial or pulsatile movement, processing and/or handling in manufacturing, lesion characteristics, procedural technique, product size selection, severe torqueing or kinking of stent (material stress/ fatigue) or interaction with the accessory devices, lesion and/or anatomy.The investigation was unable to determine a conclusive cause for the reported stent fracture.It may be possible that the xact stent was subjected to stress/ fatigue or repetitive movement due to anatomical conditions or location of the stent; however, this could not be confirmed.The stenosis, hospitalization and unintended medical intervention/additional therapy non-surgical treatment are due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that on (b)(6) 2019, an xact stent was implanted without issue, to treat a target lesion in the mildly calcified right internal carotid artery.On (b)(6) 2020, in-stent restenosis was noted and the stent was noted to be fractured.On (b)(6) 2020, angiography was performed and an 8.0 x 20 mm non-abbott stent was implanted, treating the restenosis and stent fracture.There were no adverse patient sequela and no clinically significant delay.No additional information was provided.

• 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: 11499933
• MDR Text Key: 240345327
• Report Number: 2024168-2021-02084
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2021
• 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; Required Intervention