MAUDE Adverse Event Report: AV-TEMECULA-CT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22438-19

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Stroke/CVA (1770)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Thrombectomy was attempted with two non-abbott thrombectomy devices, but no clot was aspirated; only blood.A 2nd xact stent (8tx40x136) was deployed proximally overlapping the 1st stent in an attempt to secure thrombus; but thrombus was not secured.Stroke symptoms continued.Tissue plasminogen activator (tpa) medication was given through the catheter, with no improvement to patient effects.The 3rd nav6 filter was retrieved and an accunet (1011649-65) filter was then deployed without difficulty.A 3rd stent (82092-01 xact) was deployed distal to the very 1st placed stent overlapping it, in attempt to secure thrombus, but it was not secured.The patient was still neurologically unresponsive.Integrillin (3 mg) was injected into the 3rd deployed xact stent; angiogram showed desired perfusion with no more vessel occlusion and an immediate subsequent computerized tomography (ct) scan showed no bleeding in the brain.Magnetic resonance imaging (mri) performed the next day ((b)(6) 2017) confirmed stroke had occurred on both sides of the brain (right side was much worse than left), as particles (debris) were noted on the scan.The patient was discharged (b)(6) 2017 to a stroke recovery therapy center with some returned neurological activity; there remains weakness to the left side and slurred speech.Reportedly, the patient experienced worsening of stroke symptoms (increased neurological deficit) throughout the entire procedure and it cannot be stated with certainty if the devices used worsened the stroke symptoms.No additional information was provided.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of stroke is listed in the emboshield nav6 instructions for use as a known patient effect.Based on the case information and related record review, a conclusive cause for the reported patient effect, 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.The 2nd emboshield nav6 and xact (x3) devices are being filed under separate medwatch reports.

Event Description

It was reported that on (b)(6) 2017, the patient initially presented with some signs of stroke (blurred vision and slightly impaired speech), but symptoms resolved just prior to start of procedure to treat a heavily calcified, non-tortuous right internal carotid artery (rica).An emboshield nav6 lg 190cm embolic protection system (eps) was advanced past the lesion without issue, but patient began to show signs of stroke again (same symptoms, but worse than pre-procedure).While there was no device issue, the barewire was inadvertently pulled back, which pulled the filter back to the lesion.The nav6 filter was retrieved without difficulty using the nav6 retrieval catheter (rc).A 2nd nav6 filter was deployed without issue, patient stroke symptoms (loss of speech, loss of vision) continued to worsen.An 8tx40x136 xact self-expanding stent was deployed without difficulty.Angiography showed in-stent thrombosis which occluded the vessel.Patient experienced severe headache, became completely unresponsive neurologically (stroke worsened further).The 2nd nav6 was retrieved with nav6 rc without difficulty.A 3rd nav6 was deployed without difficulty.A 4.5x15x135 rx viatrac balloon was advanced and inflated to treat thrombus and open occluded vessel, but there was no improvement to the patient effects.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION 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: 6619783
• MDR Text Key: 76946162
• Report Number: 2024168-2017-04858
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090665
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22438-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• 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): Disability
• Patient Age: 75 YR