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

Catalog Number 1125300-28

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant product: guide wire: rute, sion blue; guide cath: heartrail ii il4.0; other: guide liner 5.5fr.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 during a procedure of the mildly tortuous, mildly calcified, 90% stenosed, bifurcation and distal right coronary artery (rca), after lesion pre-dilatation the 3.0 x 28 mm xience alpine stent delivery system (sds) was advanced but could not cross the lesion due to the anatomy.The xience alpine and a guideliner were re-inserted but could not cross the lesion due to the anatomy.Additional pre-dilatation of the lesion was performed; the xience alpine and guideliner were advanced but resistance was met with the guideliner and the sds did not cross the lesion due to the anatomy.The xience alpine sds met resistance with the guideliner during removal.Outside the anatomy the xience alpine sds mid shaft was noted to be stretched.The procedure was completed using a non-abbott drug eluting stent (des) without reported issue.There was no reported adverse effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported stretched shaft, difficulty to position and difficulty to remove were able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no evidence to indicate the presence a potential 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: 5082971
• MDR Text Key: 26245987
• Report Number: 2024168-2015-05395
• 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
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Catalogue Number: 1125300-28
• Device Lot Number: 5040141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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