MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Model Number 22438-19

Device Problems Entrapment of Device (1212); Material Separation (1562); Stretched (1601)

Patient Problems Vasoconstriction (2126); Foreign Body In Patient (2687)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 complaints.The reported patient effect of vasospasm (vasoconstriction) is listed in the emboshield nav6 instruction for use, as a known possible adverse event potentially associated with carotid stents and embolic protection systems.The investigation determined that the reported difficulties, subsequent patient effect and additional treatment were related to circumstances of the procedure.Based on the reported information, interaction between the emboshield filtration element and the xact stent causing entanglement, stretched coils, vessel spasm and separation may be the result of inadequate distance maintained between the proximal end of the filtration element and the distal end of the xact stent causing the filtration element to become entangled with the xact stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a 70% stenosed, heavily tortuous, and heavily calcified lesion in the right internal carotid artery.An emboshield nav6 embolic protection system (eps) was advanced and deployed.Following pre-dilatation with a 4x20mm viatrac balloon dilatation catheter (bdc), an 8-6x40mm xact stent was deployed fully apposed to the vessel wall.Post-dilatation was performed with a 5x20mm viatrac bdc.The nav6 retrieval catheter was advanced to the proximal end of the filter and the barewire was pulled to collapse the filter into the retrieval catheter; however, the barewire coils started to stretch due to the filter being stuck at the top of stent.A snare was advanced to attempt and remove the filter, but the snare could not advance due to resistance with the deployed stent, the snare became damaged and was removed.A second snare was used and while advancing the patient was asked to move their neck and head to try and get the snare through the stent; however, the barewire coils continued to stretch.Again the snare became damaged due to hitting the deployed stent and the vessel began to spasm.Due to these factors, the second snare was unsuccessful and was removed.The barewire was removed and the filter remained in the patient anatomy.The patient was stable and it was decided to abort the procedure and leave the filter in place.When the procedure was completed, the filter was located in the mid-cervical carotid, just distal to stent.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION 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: 10187170
• MDR Text Key: 196247056
• Report Number: 2024168-2020-05286
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 9111161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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: 8-6X40MM XACT; SHEATH: 6FR X 90CM SHUTTLE FLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 116