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

Catalog Number 1070300-23

Device Problems Collapse (1099); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was reported that during the percutaneous coronary intervention a xience xpedition stent delivery system catheter (sds) would not advance on the proximal end of the balance heavyweight guide wire.Force was used to remove the sds which resulted in the tip of the sds losing its shape and becoming enlarged.The procedure was completed with a non-abbott drug eluting stent using the same balance heavyweight guide wire without any further problems.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported collapsed tip was able to be confirmed.The reported difficult to position and the reported difficult to remove the device was unable to be replicated in a testing environment as they were based on operational circumstances.Based on a visual and dimensional 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 of the electronic complaint database revealed no other similar incidents reported for collapse, difficult to position or difficult to remove from this lot.Based on the reviewed information, no product deficiency was identified.It should be noted that the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states: if removal of a stent system is required prior to deployment, ensure that the guide catheter is coaxially positioned relative to the stent delivery system, and cautiously withdraw the stent delivery system into the guide catheter.Should unusual resistance be felt at any time when withdrawing the stent towards the guide catheter, the stent delivery system and the guide catheter should be removed as a single unit.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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: 4317809
• MDR Text Key: 5243331
• Report Number: 2024168-2014-08084
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2016
• Device Catalogue Number: 1070300-23
• Device Lot Number: 4041741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: GUIDE WIRE: BALANCE HEAVYWEIGHT
• Patient Age: 76 YR