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

Catalog Number 1011710-28

Device Problems Unstable (1667); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat an 85% stenosed lesion in the moderately tortuous mid left anterior descending (lad) artery.The 3.5x28mm xience prime stent delivery system (sds) failed to cross the lesion reportedly due to interactions with the patient's anatomy, force was applied, the stent implant was noted to be moved on the balloon.As a result, all devices including the guiding catheter and guide wire were removed as a single unit.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.Another 3.5x28mm xience prime sds was used to successfully complete the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4) - against resistance.Evaluation summary: the device was returned for analysis.The loose stent was unable to be confirmed as the stent was not returned.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Based on a visual inspection of the returned device, there is no indication of a product deficiency.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.It should be noted the xience prime instructions for use (ifu) states: should any resistance be felt at any time during either lesion access or removal of the delivery system post stent implantation, the entire system should be removed as a single unit.Applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.

• Brand Name: XIENCE PRIME 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: 4110672
• MDR Text Key: 20752815
• Report Number: 2024168-2014-06127
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• 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
• Report Date: 08/29/2014

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: 09/08/2015
• Device Catalogue Number: 1011710-28
• Device Lot Number: 3082941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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