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

Catalog Number 1011730-15

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

It was reported that using a femoral artery access approach during a procedure of the heavily calcified, moderately tortuous, concentric, 99% stenosed, right coronary artery (rca) with a lesion length of 15 mm and vessel diameter of 2.2 mm the 2.25 x 15 mm xience prime stent delivery system (sds) was advanced but could not cross the lesion.During removal, resistance was met with the anatomy and the guide catheter.Once outside the anatomy proximal stent strut flare was noted.A different xience family sds was used to complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint 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 history of the reported lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE PRIME SV 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: 4358082
• MDR Text Key: 20776324
• Report Number: 2024168-2014-08462
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2016
• Device Catalogue Number: 1011730-15
• Device Lot Number: 4050741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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