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

Catalog Number 22443-19

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

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 query of the complaint handling database for the reported lot revealed no other complaints reported from this lot.Based on the information provided, the reported difficulty removing the filter resulting in surgical intervention and prolonged hospitalization were due to interaction with the ruptured viatrac balloon dilatation catheter preventing the devices from being able to withdraw into the guide catheter.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 to treat a stenosed lesion in the left common carotid artery with heavy calcification at the bifurcation.Puncture was at the right femoral artery.Pre-dilatation was performed using a 4.0x20mm viatrac balloon.An emboshield nav 6 filter was positioned and a 7.0-9.0x40mm xact carotid stent system failed to cross due to the anatomy.Another 5.0x40mm viatrac balloon dilatation catheter (bdc) was advanced with resistance to the lesion and the balloon ruptured during the first inflation at 10 atmospheres (atms).However, the balloon "stripped" on the calcification and separated with the distal part remaining in the anatomy distal to the tip of the introducer during removal.An attempt to remove all the devices was made including the guide catheter, emboshield nav 6 filter and the separated portion of the balloon using the guide wire in place but failed as the devices remained blocked due to the issue with the balloon.The procedure was immediately converted to an open surgery for a carotid-carotid bypass.Nothing remains in the anatomy.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A cine was received and reviewed by an abbott vascular clinical specialist.The target lesion is identified as a stenosed calcified left common carotid artery at the bifurcation.Using a femoral approach pre-dilation was performed with a balloon dilatation catheter (bdc), which was then removed.An embolic protection device was then inserted and placed in position.Afterwards, a carotid stent system was inserted, which failed to cross the anatomy/lesion, resulting in the stent system to be removed.A second larger bdc was then inserted, advanced, and inflated, resulting in a rupture of the balloon.An attempt to remove the bdc resulted in the part of the balloon separating within the anatomy located distal to the introducer.Unsuccessful attempt to remove devices, resulted in the patient going to surgery for bypass, as well as removal of the guide catheter, embolic protection and separated portion of the balloon.The media corresponding to this complaint shows pre-procedural images demonstrating measurements/dimensions of the left common carotid artery and 3d reconstruction of the patient¿s anatomy of interest.Procedural images are also included showing procedural devices in place.Lastly, images are included that show what appear to be the second viatrac bdc associated with the malfunction.It shows the bdc to be out of the body after it was removed surgically, where the balloon clearly shows a malfunction, where it has become split into two parts.H10: cine analysis was inadvertently left off the initial report.

• 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: 17965693
• MDR Text Key: 326049343
• Report Number: 2024168-2023-11562
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 3051161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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: 5.0X40MM VIATRAC BALLOON; COOK FLEXOR 6F 90CM; TERUMO 0,035
• Patient Outcome(s): Required Intervention; Hospitalization