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

Catalog Number 1074300-18

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat de novo lesions located in the non-tortuous, non-calcified, 90% stenosed mid and proximal left anterior descending (lad) artery.Balloon angioplasty was performed on a 99% stenosed lesion in the distal lad, after which pre-dilation was performed in the proximal lad.Optical coherence tomography was then performed.No calcification was observed and it was assumed a stent would cross the lesion easily; therefore, the 3.0x18 mm xience xpedition stent delivery system (sds) was advanced towards the lesion.With the stent/balloon area encased inside the protective sheath, the xience xpedition sds was slightly pressurized so the proximal struts got slightly expanded prior to insertion of the sds into the anatomy so that the proximal part of the stent implant sat snugly (or caught) in the ostium of the left circumflex.Although resistance was met between the xience xpedition sds and the rhv, and between the sds and the inner lumen of the guiding catheter, the xience xpedition sds reached the lesion successfully; however, did not advance into the lesion due to the distal part of the stent coming into contact with the lesion.Although the sds was pushed, it failed to cross.The xience xpedition sds was being pulled into the guiding catheter when the stent implant moved/shifted on the sds balloon outside the guiding catheter tip.The sds balloon was slightly pressurized so that the shifted stent implant was caught with the inner lumen of the guiding catheter allowing sds and the shifted stent implant to be removed without issue.A 3.0x15 mm xience xpedition stent was able to be deployed successfully.No additional information was provided.

Event Description

Subsequent to the previous medwatch filing, additional information received stated; the proximal stents struts were flared/bent intentionally so that the proximal end of the guide wire, which was placed in the side branch, was inserted through the struts.The proximal end of the guide wire which was placed in the side branch, was inserted through the flared/bent proximal struts.The flared/bent stent struts were flattened and then the stent delivery system was advanced into the anatomy.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: sion blue, sion; guide cath: autobahn buz6f.Failure to follow steps/instructions.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The loose stent was unable to be confirmed as the stent was returned dislodged from the sds.The failure to advance, difficult to position, and difficult to remove could not be replicated in a testing environment as it was based on operational circumstances.Based on a visual 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/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.It should be noted the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states: special care must be taken not to handle or in any way disrupt the stent on the balloon.Do not manipulate, touch, or handle the stent with your fingers, as this may cause coating damage, contamination, or dislodgement of the stent from the delivery system.A cine of the procedure was received and reviewed by an abbott clinical specialist.The reviewer concluded the images are consistent with stent migration.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4287853
• MDR Text Key: 5084989
• Report Number: 2024168-2014-07834
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2016
• Device Catalogue Number: 1074300-18
• Device Lot Number: 4040141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Required Intervention