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

Catalog Number 1074250-28

Device Problems Difficult To Position (1467); Difficult to Remove (1528); 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 12/13/2013

Event Type  malfunction  

Event Description

It was reported that using an unspecified artery access approach during a procedure of the heavily calcified distal, mid, and proximal right coronary artery (rca) after the guide wire was positioned across the lesion a small balloon dilatation catheter (bdc) was advanced but failed to cross.A rotablator was used and then the lesion was dilated with a bdc.The 2.5 x 28 mm xience xpedition stent delivery system (sds) was advanced to the lesion but failed to cross and was removed from the anatomy.A 4 fr non-abbott support catheter was advanced inside the unspecified guiding catheter and the 2.5 x 28 mm xience xpedition sds was advanced inside with some resistance with the inner lumen of the support catheter, but exited the support catheter.The sds still could not cross the lesion.The xience xpedition sds met resistance but was removed out of the support catheter from the anatomy; the first two rows of the stent implant struts were noted to be stretched distally and some foreign material was observed entangled/caught with the struts around the implant 4th strut row.The xience xpedition sds was not used again.A non-abbott sds was used in the procedure without reported incident.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) - re-insertion.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 stent damage and foreign material were able to be confirmed.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 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 (ifu) 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.Based on the reviewed information, no product deficiency was identified.

• 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: 3559639
• MDR Text Key: 4074110
• Report Number: 2024168-2014-00130
• 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: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2015
• Device Catalogue Number: 1074250-28
• Device Lot Number: 3071941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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
• Treatment: GUIDE WIRE: RINATO