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

Catalog Number 1125325-18

Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: the device was returned for analysis.The reported stretched shaft was unable 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.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed as the stent may be damaged or/and dislodged from the balloon when retracting the undeployed stent back into the guiding catheter.Additionally, the ifu states: although the safety and effectiveness of treating more than one lesion per coronary artery with xience alpine stents have not been established, if this is performed, place the stent in the distal lesion before the proximal lesion in order to minimize dislodgement risk incurred by traversing through deployed stents.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.Additionally, a review of the complaint history 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 manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the proximal to distal right coronary artery, which was moderately tortuous, moderately calcified and 90% stenosed.The proximal portion of the lesion was pre-dilated with a non-abbott balloon dilatation catheter, and a 4.0x15mm xience alpine stent was successfully implanted.An attempt was made to advance the 3.25x18mm xience alpine stent delivery system (sds) to the distal portion of the lesion; however, the sds would not cross the lesion due to the patient anatomy.The sds was removed from the patient anatomy.Additional pre-dilatations were performed with an unspecified bdc, and another attempt was made to advance the same sds using microcatheters.The sds still did not cross the lesion.When the sds was removed from the patient anatomy, it was noted that the distal portion of the sds shaft was stretched.Another xience alpine sds was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.Returned device analysis indicated a tear in the guide wire exit notch.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: 5599459
• MDR Text Key: 43543030
• Report Number: 2024168-2016-02591
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2018
• Device Catalogue Number: 1125325-18
• Device Lot Number: 5031841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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