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

Catalog Number 1120400-18

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant: dilatation catheter: angiosculpt, tazuna, emerge, sapphire ii.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during a procedure of the non-tortuous, non-calcified, de novo, mid left anterior descending (lad) artery, after optical computed tomography (oct), the 4.0 x 18 mm xience alpine stent delivery system (sds) was advanced, but failed to cross the lesion and was removed.Additional pre-dilatation was performed; however, the xience alpine still could not cross the lesion.The device was removed from the anatomy without reported issue and distal edge stent was noted to be flared.A non-abbott stent was deployed in the lesion.There was no reported adverse patient effect or a clinically significant delay in the procedure.Return device analysis noted green colored material on the first ring of distal struts and on the distal balloon taper.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported flared stent was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on circumstances of the procedure.Additionally, an unknown green colored material was noted on the first ring of distal struts and on the distal balloon taper.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event and a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the anatomy resulting in the reported failure to advance.The green material resembled a combination of primer green, likely due to an interaction with the guide wire and blood.The interaction with the anatomy or the re-insertion of the device likely resulted in the reported stent damage and the noted green material.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design 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: 7168545
• MDR Text Key: 96601052
• Report Number: 2024168-2018-00102
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Catalogue Number: 1120400-18
• Device Lot Number: 7091841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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