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

Model Number 1125225-28

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use 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 when retracting the undeployed stent back into the guiding catheter.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during the procedure to treat a mildly calcified lesion in the mildly tortuous right coronary artery (rca), a few attempts were made to cross the vessel with a 2.25x28 rx xience alpine stent delivery system (sds), but this device failed to cross due to patient anatomy, despite performing additional dilatation with unspecified trek balloons.During re-insertion for another crossing attempt, a thread or string (of unknown origin) was noted on the xience alpine distal shaft; reportedly, as the thread / string was pulled, it felt as if it may have been unraveling from the device.None of the string / thread was left inside of patient vasculature and no other device issues were noted.Reportedly, it is unknown if this material originates from the device itself or if it is foreign material.There were no adverse patient effects and no occurrence of a clinically significant delay.A non-abbott stent crossed the lesion.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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6684925
• MDR Text Key: 79127291
• Report Number: 2024168-2017-05630
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199103
• UDI-Public: (01)08717648199103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1125225-28
• Device Catalogue Number: 1125225-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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