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

Catalog Number 1070275-23

Device Problems Difficult To Position (1467); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

It was reported that using a femoral artery access approach during an emergency procedure of the non-calcified, non-tortuous, 100% stenosed, de novo mid left anterior descending (lad) artery two non-abbott guide wires were placed in the target lesion and a non-abbott balloon dilatation catheter (bdc) was also placed.It was noted that the 3 devices remained in the guide catheter and the 2.75 x 23 mm xience xpedition stent delivery system (sds) was advanced but met resistance during advancing and became stuck in the 6 fr guide catheter and it was noted that the sds stent struts became bent; the sds and the bdc were removed separately/individually without reported issue.The guide catheter and the two (2) guide wires remained in the anatomy.A different 2.75 x 23 mm xience prime sds was inserted first through the guide catheter then a non-abbott bdc was inserted through the guide catheter.The bifurcation lesion was treated with success; the final outcome was very good, there were no adverse patient effects.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed green foreign material on the stent implant and the guide wire exit notch was torn.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: 2 asahi sion; guide cath: 6f guiding catheter.The device was returned for analysis.The stent damage was able to be confirmed.The difficulty advancing the sds in the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.An interaction with these devices likely contributed to the stent and shaft damages.The green foreign material located on the stent is consistent with the teflon coating of the guide wires, which came in contact with the sds during advancement.Based on a visual and dimensional 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 database revealed no other similar incidents reported from this lot.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: 3774098
• MDR Text Key: 4356653
• Report Number: 2024168-2014-02639
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2016
• Device Catalogue Number: 1070275-23
• Device Lot Number: 4011441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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