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

Catalog Number 1011344-40

Device Problem Material Deformation (2976)

Patient Problem Stroke/CVA (1770)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A 7-10 x 30 mm acculink stent was advanced, with the thought that perhaps the tapered size would allow the stent to cross, but it was unable.The device was removed without difficulty.The procedure was reviewed and it was noted that the filter had caught on the distal portion of the stent, so that each time the retrieval catheter was pulled to remove, the filter would pop out of the retrieval catheter.The procedure ended with the patient in stable condition.On (b)(6) 2017, the patient began to experience right-sided weakness.Computed tomography (ct) and magnetic resonance imaging (mri) were performed and micro emboli were noted.Cardiovascular accident (cva) was diagnosed.Heparin was administered and the neurologist felt that the event would resolve.The physician will determine if additional intervention, possibly endarterectomy, is needed at a later date.No additional information was provided.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The reported patient effects of cerebrovascular accident, as listed in the instructions for use, is a known adverse event associated with the use of carotid device in native carotid arteries.The investigation was unable to determine a conclusive cause for the reported difficulties and patient effect and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The emboshield nav6 embolic protection device referenced is filed under a separate medwatch report.

Event Description

It was reported that the carotid procedure was performed to treat a target lesion in the mildly calcified and moderately tortuous internal carotid artery.The emboshield nav6 embolic protection device was deployed without issue.The 7.0-10 x 40 mm acculink stent was then deployed without difficulty; however, it was noted that there remained some stenosis and additional dilatation was performed to fully expand the stent to the vessel wall.The emboshield retrieval catheter was advanced to retrieve the emboshield filter; however, there was some resistance noted advancing the retrieval catheter through the acculink stent.The retrieval catheter seemed to be catching on the stent struts.During advancement of the retrieval catheter, the bare wire guide wire and emboshield filter were pulled closer to the distal end of the stent.The retrieval catheter was finally able to advance through the deployed acculink stent and captured the filter.However, as the retrieval catheter was pulled back, it was noted that the filter would pop out of the retrieval catheter.This occurred multiple times.The physician was then able to capture the filter in the retrieval catheter, and pulled with some force to remove the retrieval catheter with the captured filter.It was then noted that the stent was being pulled in on itself at the distal portion.The retrieval catheter and filter were finally able to be removed from the patient anatomy.Multiple balloon dilatation catheters were advanced to the stent and inflated.During inflation, the stent was opened.The dilatation catheters were removed and it was noted that the nitinol in the stent would not allow the stent to remain open at the distal portion of the stent.Additional devices were advanced, but were unable to cross.

• Brand Name: RX ACCULINK 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: 6759063
• MDR Text Key: 81562933
• Report Number: 2024168-2017-06334
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 1011344-40
• Device Lot Number: 7040461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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; Disability