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

Catalog Number 1125350-28

Device Problems Difficult To Position (1467); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

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: guide wire: sion blue, fielder fc.Guide cath: hyperion 6f spb, guideliner 6f v3.Stent: xience alpine 2.5x23mm.(b)(4).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 that the procedure was to treat a concentric, 60mm long de novo lesion, extending from the left main coronary artery (lmt) through the proximal and mid left anterior descending artery (lad).There was heavy calcification, heavy tortuosity and 90% stenosis.After lesion pre-dilatation was performed, two xience alpine stents were successfully implanted, overlapping, in the proximal lad.A 3.5x28mm xience alpine stent delivery system (sds) was advanced in order to implant it overlapping proximally with the previously implanted stents; however, the sds could not cross the lesion.Additional dilatation was performed and the 3.5x28mm xience alpine sds was re-inserted into the patient anatomy, but still was unable to reach the distally implanted stent to overlap.Several attempts were made, and it was noted that the guiding catheter and the guideliner appeared to be disengaged from the coronary anatomy.Additionally, angiography indicated the 3.5x28mm xience alpine stent shifted on the balloon, probably due to guideliner contact with the stent and the proximal end of the stent looked smashed.The sds was inflated and the stent was deployed.Post-dilatation was performed and it was confirmed by ivus that the stent was fully expanded and successfully deployed in the lesion, resulting in 0% stenosis.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The loose and damaged stent was unable to be confirmed as the stent was not returned.The difficult to position could not be replicated due to the condition of the returned device.The physical resistance could not be replicated in a testing environment as it was based on operational circumstances.Based on a visual 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 issued to the reported lot that would have contributed to this event.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.

• 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: 5291793
• MDR Text Key: 33889601
• Report Number: 2024168-2015-07520
• 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: 12/21/2015

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: 05/21/2018
• Device Catalogue Number: 1125350-28
• Device Lot Number: 5051841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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