MAUDE Adverse Event Report: AV-TEMECULA-CT XACT CAROTID STENT SYSTEM

Catalog Number 82094-01

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467); Device Damaged by Another Device (2915)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolism (1829)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.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 incidents.The reported patient effect of embolism is a known, observed and potential patient effect as listed in the xact instructions for use.The investigation determined that the reported difficulties, subsequent patient effects and additional treatments are due to case circumstances.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 emboshield nav6 device referenced is filed under a separate medwatch mfr number.

Event Description

It was reported that during a heavily calcified ostial left common carotid (lcc) artery stenting procedure, after placement of the emboshield nav6, embolic protection device (epd), the 7x30 xact stent was positioned and ready to be deployed.Somehow, the stent deployed mostly in the aorta with only a small portion in the lcc ostium.As a result, nothing could get past the implanted stent, including the retrieval catheter for the epd; therefore, the epd was pulled through the stent to the retrieval catheter.However, the epd caught on the stent, dislodging it.The dislodged stent then floated downstream.The carotid intervention was completed with a non-abbott stent and the dislodged xact stent was pulled with a balloon to the iliac bifurcation where it was embedded in the vessel wall with a non-abbott stent.There was no adverse patient sequela and no clinically significant delay in procedure.There was no additional information provided.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT 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: 5707724
• MDR Text Key: 46855010
• Report Number: 2024168-2016-03745
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 82094-01
• Device Lot Number: 6011261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 73