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

Catalog Number 1074350-38

Device Problems Difficult to Insert (1316); Unstable (1667); Material Deformation (2976); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat an unknown lesion.As the xience xpedition 3.5 x 38 mm stent delivery system (sds) was advanced through the co-pilot into the guide catheter, it felt gritty.Thus, the sds was removed from the catheter and it was observed that some of the distal struts were flared.The sds was never advanced into the body of the patient, only advanced a small length of the guide catheter outside the body.A new stent delivery system was then opened and deployed without issue.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Based on a photo received from the account, the stent had moved distally on the balloon.

• 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7260867
• MDR Text Key: 100039426
• Report Number: 2024168-2018-00966
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162589
• UDI-Public: 08717648162589
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: 1074350-38
• Device Lot Number: 7112741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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