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

Catalog Number 82090-01

Device Problem Material Deformation (2976)

Patient Problem Prolapse (2475)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified lesion in the carotid artery.A 4.0 x 136 mm xact stent was successfully implanted in the carotid artery.During a routine evaluation post implantation on the same day, it was discovered that the heavy calcium crushed the stent closed.The patient was kept overnight for observation and medication was administered.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

(b)(4).The product was not returned to abbott vascular 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 identified no other similar incidents reported from this lot.The investigation determined that the reported stent damage appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 7485429
• MDR Text Key: 107313857
• Report Number: 2024168-2018-03292
• 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,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 82090-01
• Device Lot Number: 7071261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 91