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

Catalog Number 1009544-28

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problems Stroke/CVA (1770); Renal Failure (2041)

Event Date 04/23/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the tortuous right coronary artery (rca).A 2.25x28mm xience nano stent delivery system (sds) was successfully advanced and the stent was successfully deployed in the proximal lesion.A second 2.25x28mm xience nano sds was dipped in saline prior to use and negative prep was performed inside the patient's anatomy.During advancement through the deployed stent to treat the distal lesion, the stent implants became caught.The second xience nano sds could not be advanced or removed.The guiding catheter was deep-seated in an attempt to disengage the two stents; however, this was unsuccessful.An attempt was made to deploy the stent in its current position; however, the device failed to inflate and a balloon leak was noted.Although force was applied, further attempts to withdraw the device were unsuccessful.The guiding catheter was removed and the sheath was changed from a 6-french to an 8-french.All devices were then removed as a single unit, and the procedure was stopped.There was a clinically significant delay in the procedure.Reportedly, the patient experienced a stroke and was transferred to the intensive care unit (icu).The patient remains hospitalized in renal failure.The distal lesion was never treated.It is unknown what, if any treatment was provided for the stroke or renal failure.No additional information was provided.

Manufacturer Narrative

(b)(4): against resistance, incorrect prep, distal to stent.The additional xience nano device referenced is being filed under a separate medwatch report.It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.The reported patient effects of cerebrovascular accident (stroke) and renal failure are known observed and potential patient effects as listed in the xience v and xience nano everolimus eluting coronary stent system electronic instructions for use.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.

• Brand Name: XIENCE V 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: 3809187
• MDR Text Key: 18921793
• Report Number: 2024168-2014-03064
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2015
• Device Catalogue Number: 1009544-28
• Device Lot Number: 2121841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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: STENT: 2.25X28MM XIENCE NANO
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 69 YR