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

Catalog Number 82087-01

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2013, the index procedure was to treat a heavily calcified lesion in the internal carotid artery.During deployment of the 9.0x40x136 xact, the stent jumped forward and was deployed partially in healthy tissue and partially in the target lesion.An unplanned 9.0x30x136 xact stent was deployed overlapping to treat the remainder of the target lesion.The procedure was completed without any adverse patient sequela or clinically significant delay in the procedure.On (b)(6) 2014, during regular angiographic check-up, it was noted that the overlapping portion of the two deployed stents had fractured struts.A non-abbott balloon dilatation catheter (bdc) was successfully advanced; however, the balloon ruptured during inflation.As the patient is non-symptomatic and the vessel is not blocked, the decision was made to abort further treatment and continue regular monitoring.The procedure was completed without any adverse patient sequela or clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).The 9.0 x 40 x 136 xact carotid stent mentioned is being filed under a separate manufacturer report number.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.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: 3812978
• MDR Text Key: 16774783
• Report Number: 2024168-2014-03069
• 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: 05/01/2014

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 Catalogue Number: 82087-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: STENT: 9.0X40X136 XACT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR