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

Catalog Number 1125225-15

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: runthrough ns floppy.Guide catheter: heartrail jr4.0.(b)(4).Prior to use, stent was touched.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that while preparing the 2.25x15mm xience alpine stent delivery system (sds), the protective sheath was removed and an unusual feeling was noted.While inserting a guide wire into the sds, the same unusual texture was noted.Prior to anatomy insertion, the sds was removed from the guide wire and stent inspected.The physician touched the stent and the stent dislodged.The device was replaced with a non-abbott device.The procedure was completed successfully.There were no reported adverse patient effects and no clinically significant procedural delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported physical property issue/irregular texture was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The xience alpine everolimus eluting coronary stent system (eecss), domestic instructions for use states: do not manipulate, touch or handle the stent with your fingers, which may cause coating damage, contamination or stent dislodgement from the delivery balloon.A conclusive cause for the reported difficulties cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5805793
• MDR Text Key: 49952917
• Report Number: 2024168-2016-04725
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2018
• Device Catalogue Number: 1125225-15
• Device Lot Number: 5112741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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