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

Catalog Number 82090-01

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a right carotid artery.Physician thought the delivery sheath looked different than normal but decided to use the device anyway.A non-abbott protection device was advanced to the lesion; however, when advancing through a 6f sheath there was a lot of drag felt.When attempting to deploy the stent, the deployment actuator would not turn.The stent deployed slightly, but did not flower so the stent was pulled back into the sheath.An attempt was made to remove the stent delivery system; however, it pulled all the devices with it and the stent dislodged and got stuck in the access sheath.A cutdown at the access site was made and vessel loops were used to maintain hemostasis.A new access sheath was advanced and a non-abbott protection device and same size xact were successfully used to complete the procedure.There was a clinically significant delay in the procedure as it took over to hours to complete.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The stent dislodgement was able to be confirmed.The failure to deploy was not able to be confirmed as the stent was not returned.Based on a visual and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

• 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4141086
• MDR Text Key: 15913170
• Report Number: 2024168-2014-06428
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 82090-01
• Device Lot Number: 3090461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 66 YR