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

Catalog Number 1070300-23

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported material deformation was able to be confirmed.Additionally, the stent implant was stationary on the balloon, but not between the markers.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the mildly tortuous, heavily calcified and 80% stenosed anatomy resulting in the reported failure to advance.As the device was withdrawn interaction with the anatomy and/or other devices resulted in the reported flared stent struts thus resulting in the noted stent mislocation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported the procedure was to treat mildly tortuous, heavily calcified, 80% stenosed de novo lesion in the proximal left anterior descending (lad) coronary artery.A 2.5x20 mm trek balloon dilatation catheter (bdc) was used to pre-dilate the lesion.The 3.0x23 mm xience xpedition stent delivery system (sds) was advanced in the patient anatomy; however, the sds got stuck in the middle of the lesion, failed to cross.The sds was removed without issue and it was noted that the proximal stent struts were flared.There were no adverse patient effects and no clinically significant delay during the procedure.The patient was sent to surgery because no other device crossed the target lesion.No additional information was provided.Return device analysis revealed that the stent had moved distally and was mislocated on the balloon.

• Brand Name: XIENCE XPEDITION 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: 6311414
• MDR Text Key: 67167543
• Report Number: 2024168-2017-01021
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648157905
• UDI-Public: (01)08717648157905(17)190803(10)6072341
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Catalogue Number: 1070300-23
• Device Lot Number: 6072341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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
• Patient Age: 52 YR
• Patient Weight: 92