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

Catalog Number 22438-19

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Movement was restored to left lower extremity, significant motor impairment of the left upper extremity was still present, patient was able to somewhat adjust posture, patient had no right side symptoms, and patient was responsive to commands.Patient speech status remains unknown due to recent extubation.Physician remains hopeful of continued patient recovery.No additional information was provided.Concomitant medical products: guide catheter: 6fr shuttle guiding sheath, stent: rx acculink ii.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The reported patient effects of cerebrovascular accident and neurological deficit/dysfunction are listed in the informations for use as known patient effects that may be associated with use of a peripheral stent in native peripheral arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The rx acculink ii device referenced in describe event or problem and concomitant medical products is being filed under a separate manufacturing report number.

Event Description

It was reported that the procedure performed on (b)(6) 2017 was to treat a non-calcified lesion in the very tortuous right internal carotid artery (rica) (2 cm distal to a bifurcation).After positioning a 6fr non-abbott guiding sheath, an emboshield nav6 embolic protection system (eps) delivery catheter with filter was prepped without issue and the filter was deployed distal to the lesion.An rx.014 acculink ii 6-8/40 stent was deployed without difficulty.The emboshield nav6 retrieval catheter (rc) was advanced; the rc was unable to completely cross through the acculink stent due to vessel tortuosity.During the attempt to cross, the non-abbott guiding sheath consequently became unseated / prolapsed due to vessel tortuosity, pulling the wire and filter proximally, resulting in the filter being snagged by the implanted stent.No damage was caused to the stent.The non-abbott sheath could not be re-seated due to the tortuosity.Two viatrac 14 balloons were used for attempts to retrieve the filter.After approximately 7 hours of attempting to retrieve the filter, a dissection was noted at the stent (with the dissection cause unknown); the dissection was successfully treated via placement of two unspecified stents.The patient was then transferred to surgery and the filter was successfully retrieved.A computerized tomography (ct) scan showed a watershed stroke with perfusion, reportedly likely caused by the filter removal surgery, as the rica was clamped distal to the device.The patient was intubated.On (b)(6) 2017, the patient was extubated with the following status:.

• 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: 6454561
• MDR Text Key: 71543842
• Report Number: 2024168-2017-02761
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)180930(10)5101561
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 22438-19
• Device Lot Number: 5101561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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; Disability
• Patient Age: 77 YR
• Patient Weight: 91