MAUDE Adverse Event Report: AV-TEMECULA-CT XACT CAROTID STENT SYSTEM

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 04/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Finally, carotid revascularization was performed successfully, proven by post procedural angiogram.At the 10 month follow up, the patient showed no signs of neurological deficits, without any evidence of restenosis or occlusion after carotid artery stenting proven by duplex ultrasonography.No additional information was provided.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.Attachment, article titled: acute in-stent thrombosis after carotid angioplasty and stenting.

Event Description

The following information was reported from an article titled " acute in-stent thrombosis after carotid angioplasty and stenting": the patient presented with hypertension and was hospitalized for an episode of transient ischemic attack.Angiography revealed an almost complete left carotid artery occlusion.After a cerebral protection filter had been positioned, the stenosis of the left internal carotid artery was pre-dilated with a 3.0x20mm balloon and a 4.0x30mm viatrac 14 plus balloon.An 8x30mm xact self-expanding stent was then implanted.The first post procedural angiogram showed the carotid stent was not well apposed and post-dilatation was performed with a 5.0x20mm balloon at 10 atmospheres (atm).However, a repeat angiogram showed in-stent thrombosis 2 minutes after withdrawal of the cerebral protection filter.The patient showed no neurological deficit.After an additional 2,000 units of heparin had been administered intravenously, a microcatheter was positioned to the in-stent thrombosis.Next, a total dose of 10mg of recombinant tissue plasminogen activator was injected into the thrombus via the microcatheter within 10 minutes, which led to partial recanalization with antegrade flow.However, complete occlusion of the lesion occurred 5 minutes after carotid thrombolysis according to the repeat angiogram.Under the guidance of angiography roadmap, a nav6 embolic protection filter was deployed at the distal part of the stent, and re-dilation of the stent was performed with a 5.0x30mm viatrac 14 plus at 14 atm.

Manufacturer Narrative

(b)(4).Udi#: in the absence of a reported part number, the udi cannot be calculated.The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.Deployment difficulties may be due to, but not limited to, patient anatomical conditions, patient disease state, using an undersized stent, pre-dilatation strategy or device placement technique.It may be possible that anatomical conditions contributed to the difficulty; however, this could not be confirmed.The reported patient effects of occlusion and thrombosis are listed in xact carotid stent systems instructions for use as known patient effects of the stenting procedure.The investigation was unable to determine a conclusive cause for the reported difficult to deploy and patient effects of occlusion and thrombosis.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7626695
• MDR Text Key: 111974590
• Report Number: 2024168-2018-04795
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• 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): Required Intervention
• Patient Age: 79 YR