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

Catalog Number 1120275-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the left anterior descending artery and the obtuse marginal artery that was tortuous but not calcified.The lesion was in a bifurcation; therefore, a double guide wire technique was used.Guide wire wrapping occurred due to confirmed operator error which caused resistance during advancement of the 2.75 x 15 mm xience alpine stent delivery system (sds).Resistance was also felt during retraction of the sds from the patient due to the wrapping issue and it was observed that 3 mm of the distal shaft had lifted and separated from the hypotube at the guide wire exit notch; however, the device is confirmed to be still in one piece.The sds was able to be removed by itself leaving the guide wires in place.Another xience sds was used to complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.Another sds was used to complete the case successfully.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The difficult to position and remove the guide wire was not confirmed.The damage to the shaft was confirmed.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 other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.

• Brand Name: XIENCE ALPINE 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: 5922598
• MDR Text Key: 54350310
• Report Number: 2024168-2016-05876
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2019
• Device Catalogue Number: 1120275-15
• Device Lot Number: 6022541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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