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 Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The product was not returned to abbott vascular 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 did not indicate a lot specific quality issue.In this case, there was no damage noted to the sds during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure, as it is likely that as the sds was advanced then met resistance with the moderate tortuosity and 90% stenosis anatomy causing the reported failure to advance and shaft kink.Additionally, inadvertently mishandling and/or manipulation of the device resulted in the reported shaft separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported the procedure was to treat a de novo lesion with moderate tortuosity, no calcification and 90% stenosis in the mid right coronary artery (rca).A non-abbott guide wire was advanced to the target lesion and pre-dilatation was performed with a 2.0 x 20 mm non-abbott balloon catheter.The 2.5 x 38 mm xience expedition stent delivery system (sds) was advanced, but could not cross the lesion due to the anatomy.The physician felt the shaft kinked; therefore, removed the device from the patient anatomy.Outside the patient anatomy, while checking the status of the kink, the shaft separated in two pieces.A non-abbott device was used to complete the procedure successfully.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.

• 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: 7161560
• MDR Text Key: 96624412
• Report Number: 2024168-2018-00038
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/03/2018

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: 10/11/2019
• Device Catalogue Number: 1070250-38
• Device Lot Number: 6093041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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