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

Catalog Number XRX04008T

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

It was reported that after unpacking an xact freestyle tapered 40x8-6 mm stent delivery system, before inserting the device into the introducer, the device (delivery system) broke.There was no reported patient involvement.It was not specified how the procedure was completed.The procedure was completed with no reported patient effects.No additional information was provided.

Event Description

Subsequent to the previously filed medwatch report, new information received as follows: no resistance was felt during removal of the sds from the hoop or during removal of the protective sheath/mandrel.There was no clinically significant delay in the procedure due to the device issue.The procedure was completed using a new xact device.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported separation was confirmed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The results of the query of similar incidents in the complaint handling database for this lot revealed no other similar incidents.Based on the reviewed information, no product deficiency was identified.

Manufacturer Narrative

(b)(4).Date of event - estimated.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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: 3854338
• MDR Text Key: 4409689
• Report Number: 2024168-2014-03650
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: XRX04008T
• Device Lot Number: 3120961
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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