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

Catalog Number 1125350-33

Device Problems Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Udi: (b)(4).Evaluation summary: the device was returned for analysis.The reported material deformation and difficulty to position was able to be confirmed.Additionally, the guide wire exit notch was torn for a length of 1 mm distally.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 and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no similar incidents reported for this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.It should be noted that the xience alpine eluting coronary stent system instructions for use (ifu) states: note: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.Maintain guide wire placement across the lesion and remove the delivery system and guiding catheter as a single unit.

Event Description

It was reported that the procedure was to treat 90% stenosed, de novo lesion with mild tortuosity and mild calcification in the mid right coronary artery (rca).The xience alpine stent delivery system (sds) attempted to advance to the target lesion with slight resistance noted with the guiding catheter.Multiple attempts were made to advance the sds, but the device could not cross the lesion.The device was removed from the patient anatomy.The proximal edge of the stent implant was not to have lifted struts.There was no reported adverse effect and no reported clinically significant delay in the procedure.No additional information was provided.Returned device analysis revealed the guide wire exit notch was torn for a length of 1 mm distally.

• 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: 5008291
• MDR Text Key: 24206987
• Report Number: 2024168-2015-04686
• 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: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2018
• Device Catalogue Number: 1125350-33
• Device Lot Number: 5020241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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