MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1165400-23

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported that during a procedure of the heavily calcified, heavily tortuous, anastomosis of the lower leg peroneal trunk the 4.0 x 23 mm xience xpedition stent was deployed without reported issue.During removal of the stent delivery system (sds) resistance was met.Once outside the anatomy, it was noted that the radiopaque marker of the balloon was missing.Under fluoroscopy the marker was located in the stent implant.A non-abbott snare was used to successfully remove the balloon material from the implanted stent.The stent implant was noted to be patent and the patient outcome was noted to be good.There was no adverse patient sequela or a clinically significant delay in the procedure reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The stent remains in the vessel.It is indicated that the device delivery system is not returning for evaluation; therefore, a failure analysis of the device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the complaint database revealed no other similar incidents reported from this lot.It should be noted the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states: the xience xpedition stent system is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; 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: 4371750
• MDR Text Key: 5112068
• Report Number: 2024168-2014-08566
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• 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: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2015
• Device Catalogue Number: 1165400-23
• Device Lot Number: 211204A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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