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

Catalog Number 1125225-08

Device Problems Difficult To Position (1467); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: dilation catheter: canpass 1.5 x 15 mm.Guide wire: sion.Guide catheter: 7f launcher.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure to treat a lesion in the proximal circumflex (cx) coronary artery.The 2.25 x 8 mm xience alpine stent was advanced and deployed at 10 atmospheres (atm) and then at 18 atm.Then, to perform post-dilatation, a 2.5 x 8 mm non-abbott balloon catheter was advanced, but the balloon catheter got caught with the edge of the deployed alpine stent and at this time the guide wire also came out of the lesion.Thus, the guide wire was re-advanced but it got caught with the edge of the deployed stent as well.The guide wire was replaced with a new guide wire and advanced, but also got caught with the edge of the alpine stent implant.Then, with the support of the micro-catheter, the guide wire was advanced again, but did not cross.Therefore, the guide wire tip was re-shaped like a knuckle.However, as the guide wire was being advanced, the tip happened to go between the vessel wall and the stent struts, as if the guide wire was woven between the vessel and the stent struts, causing the guide wire sticking with the stent.The tip of the guide wire was shaped like a ball as a result.Thus, in an attempt to detangle the ball-shaped tip, torque was applied, but the guide wire remained stuck with the stent implant.A micro-catheter was advanced close to the entangled guide wire tip and pulled with slight resistance and removed.Then, once the guide wire was outside the patient anatomy, it was observed the stent implant had been removed with the guide wire.The patient condition remained stable, thus, the procedure was continued and a 2.5 x 8 mm xience alpine stent was deployed.There was no adverse patient effect reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.Visual inspections were performed on the returned device.The device damaged by another device was able to be confirmed.The difficult to position could not be replicated in a testing environment as it was based on operational circumstances.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 similar 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 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: 6031215
• MDR Text Key: 57563775
• Report Number: 2024168-2016-06955
• 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: 11/09/2016

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: 02/17/2019
• Device Catalogue Number: 1125225-08
• Device Lot Number: 6021141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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
• Patient Age: 67 YR