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

Catalog Number 1070250-38

Device Problems Inflation Problem (1310); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure of the minimally tortuous, unspecified vessel, the 2.5 x 38 mm xience xpedition stent was positioned at the lesion and the balloon was pressurized to 14 atmosphere (atm), but the stent did not expand.The device was removed from the anatomy and the stent was not tightly crimped on the balloon.A different stent was implanted to complete the procedure.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).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported inflation issue was able to be confirmed.The reported unstable stent was unable to be confirmed.The stent implant was stationary on the tightly folded balloon between the markers.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 of the complaint database revealed no other similar incidents reported for inflation issue or unstable stent 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: 4519266
• MDR Text Key: 5536255
• Report Number: 2024168-2015-00813
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2016
• Device Catalogue Number: 1070250-38
• Device Lot Number: 4091141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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