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

Catalog Number 1074250-38

Device Problems 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 07/01/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure of the heavily calcified, moderately tortuous, 90% stenosed mid to proximal left anterior descending (lad) artery of a tandem lesion after pre-dilatation of both lesions a 3.0 x 23 mm xience xpedition stent was deployed successfully at the proximal lad.A 2.5 x 38 mm xience xpedition stent delivery system (sds) was advanced to the mid lad with the use of a guideliner but it could not cross.Additional dilatation was performed several times trying to deliver the sds to the lesion using the guideliner without success.It was noted that the distal stent struts were bent; the device and guideliner were removed separately from the anatomy without reported issue.Outside the anatomy there was damage and torn material noted at the proximal end of the rapid exchange lumen.The procedure was completed using non-abbott drug-eluting stents and a non-abbott microcatheter without reported issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant product: microcatheter: dio.(b)(4) - re-insertion.The device was returned for analysis.The stent damage and torn shaft were able to be confirmed.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Based on a visual and dimensional 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.The results of the query of similar incidents in the complaint handling database for this 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 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.

• 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: 3951319
• MDR Text Key: 16775425
• Report Number: 2024168-2014-04700
• 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
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2015
• Device Catalogue Number: 1074250-38
• Device Lot Number: 3102941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: 85 YR
• Patient Weight: 82