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

Catalog Number 1074275-18

Device Problems Inflation Problem (1310); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2014

Event Type  malfunction  

Event Description

It was reported that using a radial artery access approach during a procedure of the heavily calcified, 75% stenosed, left anterior descending (lad) artery with a vessel diameter of 2.75 mm and lesion length of 15 mm, pre-dilatation with a 2.5 mm trek balloon dilatation catheter (bdc) was performed.During advancement of the 2.75 x 18 mm xience xpedition stent delivery system (sds), resistance was met with the guide catheter, but the sds was able to reach the lesion.The sds was pressurized but did not hold pressure.At around 10 atmospheres (atm) the balloon would no longer inflate, leaving the stent partially expanded in a dog bone shape with the middle part firmly mounted on the balloon.It was unknown if the issue was due to a rupture or a tear in the shaft.The sds with the stent attached was removed from the anatomy without reported issue.A 2.75 x 15 mm xience xpedition was deployed in the lesion without issue.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).Concomitant products: dil cath: trek 2.5 x 15 mm; guide wire: sion blue; guide cath: 6fr sheathless.The device was returned for analysis.The inflation issue was able to be confirmed.The difficult to position could not be replicated in a testing environment due to the condition of the returned device.Based on a visual, dimensional, and functional 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 for difficult to position or inflation issue 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: 4358230
• MDR Text Key: 5203771
• Report Number: 2024168-2014-08464
• 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: 06/16/2016
• Device Catalogue Number: 1074275-18
• Device Lot Number: 4061141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• 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?: Yes
• Date Device Manufactured: 06/01/2014
• 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