MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCUNET EMBOLIC PROTECTION SYSTEM

Catalog Number 1011651-55

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported separation was confirmed.The migration was not confirmed as it was based on case circumstances.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 of the reported lot revealed no other similar incidents.The investigation determined the reported difficulties were due to case circumstances.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 an 80% stenosed, mildly tortuous, and mildly calcified de novo lesion in the internal carotid artery.A 5.5mm rx accunet embolic protection device (epd) was prepared per instructions for use without issues.The epd was placed about 5 centimeters (cm) above the stent intended site.An unspecified stent was implanted and post-dilated.During removal of the balloon it was noticed that the epd filter moved down with the balloon through the stent.It was not possible to hold the epd in place or advance it in the right position.The filter came down into the guiding catheter and it was noticed that the distal 25 cm of the epd device was separated from the wire part.This lead to the filter also separating.The guiding catheter and distal part of the epd were removed.The inspection of the device showed that the epd separated about 25 cm away from the filter tip from the rest of the wire.The procedure was performed successfully with the device and the patient is doing well.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: RX ACCUNET 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: 6725461
• MDR Text Key: 80629803
• Report Number: 2024168-2017-06011
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K081549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1011651-55
• Device Lot Number: 6120661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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