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

Catalog Number 1070250-23

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a highly calcified lesion in the marginal circumflex coronary artery.While attempting to insert a 2.25x15 mm xience xpedition stent delivery system (sds) into an unspecified 6 french guide catheter, the stent struts flared due to interaction with the guide catheter and the sds was removed.The sds did not enter the patient anatomy.While attempting to insert a new 2.50x23 mm xience xpedition sds into an unspecified 6 french guiding catheter, the shaft kinked and separated.The sds did not enter the patient anatomy.While attempting to insert a new 2.25x12 mm xience xpedition sds into an unspecified 6 french guide catheter, the stent struts flared due to interaction with the guide catheter and the sds was removed.The sds did not enter the patient anatomy.A new unspecified 7 french guide catheter was used and the lesion was ultimately treated with 2 new xience xpedition stents.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The shaft separation was able to be confirmed.The kink was unable to be confirmed; however, it is likely that the shaft separated at the kinked location.The difficulty inserting the stent delivery system into the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 electronic complaint database revealed no other similar incidents reported for difficult to insert into the guiding catheter, kink, or shaft separations 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: 4573600
• MDR Text Key: 5552936
• Report Number: 2024168-2015-01224
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/10/2015

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: 11/25/2016
• Device Catalogue Number: 1070250-23
• Device Lot Number: 4112041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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