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

Catalog Number 1009531-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

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.Elevant information.The bmw guide wire is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the proximal left anterior descending artery that was moderately tortuous and moderately calcified.A 4.0 x 15 mm xience v stent delivery system (sds) was advancing when the stent became stuck with a 014 balance middle weight hydro guide wire.The sds was removed with the guide wire as a single unit.The procedure was successfully completed with a 3.5 x 15 mm xience v stent and a new unspecified guide wire.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis with the inner and outer members separated distal to the guide wire exit notch.Follow-up was performed with the site; however, no additional information could be provided.The reported difficult to position was confirmed through observation and the reported difficult to remove was not confirmed due the condition of the returned device.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 identified no similar incidents from this lot.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.

• Brand Name: XIENCE V 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: 7488548
• MDR Text Key: 107565152
• Report Number: 2024168-2018-03330
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• 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,Followup
• Report Date: 06/06/2018

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: 11/08/2018
• Device Catalogue Number: 1009531-15
• Device Lot Number: 6110441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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