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 Problem Thrombosis/Thrombus (4440)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Actual patient weight is (b)(6).The udi is unknown because the part number and lot number were not provided.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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of thrombosis is listed in the x.Act carotid stent system instructions for use as a possible adverse event associated with the use of this product.The treatment 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.

Event Description

It was reported that the procedure was to treat the right internal carotid artery (ica) with total occlusion at the origin.A whisper guide wire was attempted to be advanced but could not cross without a non-abbott diagnostic catheter.The whisper wire was then used throughout the procedure without reported issues.A non-abbott embolic protection system was placed.A non-abbott balloon dilatation catheter (bdc) was then used and a flow limiting dissection was noted.A 10-8x40 mm xact stent was implanted and aspiration was performed due to concerns for thrombus located distal to the stent.To treat the dissection a non-abbott covered stent was implanted first and then the 4.5x26 mm graftmaster covered stent was implanted and the issue was resolved.The graftmaster covered stent did not cause or contribute to complications or adverse events.A residual dissection flap was noted; however, this was not noted to be flow limiting and therefore it was decided to observe the patient on dual antiplatelet therapy and perform imaging in 4-6 weeks.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: 12507579
• MDR Text Key: 272507053
• Report Number: 2024168-2021-08375
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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?: Yes
• Date Manufacturer Received: 09/01/2021
• 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
• Treatment: WHISPER GUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 84