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

Catalog Number 1125250-18

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Concomitant medical products: dil cath: kusabi, guide wire: sion black, grandslam, guide cath: hyperion, other: guide catheter extension, carabell microcatheter.

Event Description

It was reported that the procedure was to treat a concentric lesion in the proximal left circumflex artery with moderate tortuosity and 99% stenosis.A non-abbott guide wire was advanced with resistance toward the target lesion.A 2.5x18mm xience alpine rx stent delivery system (sds) was advanced toward the target lesion and failed to cross due to the anatomy.Then, a non-abbott guide wire was advanced toward the left anterior descending artery with the support of a non-abbott microcatheter.The xience alpine was advanced a second time and met resistance with a guide catheter and the microcatheter.An attempt was made to deliver a non-abbott catheter to remove the microcatheter; however, the xience alpine was inadvertently pulled back by mistake.During inadvertent pulling of the xience alpine, it met strong resistance with the guide catheter/microcatheter; hence, a mid-shaft separation occurred.The separated portion of the shaft was simply removed with the guide catheter as a single unit.Ultimately the lesion was treated by implanting a new xience alpine stent.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The shaft separation was able to be confirmed.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.The difficult to position and device damaged by another device 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 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.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.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.

Event Description

Subsequent to the previously filed medwatch, additional information indicates that a non-abbott catheter was advanced to help remove a non-abbott microcatheter but the non-abbott catheter failed to cross, thus it was removed.Then, an attempt was made to remove the non-abbott microcatheter by itself but the xience alpine sds was pulled by mistake.No additional information was provided.

• 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: 5414019
• MDR Text Key: 37734332
• Report Number: 2024168-2016-00655
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/25/2016

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: 10/06/2018
• Device Catalogue Number: 1125250-18
• Device Lot Number: 5092241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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