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

Catalog Number 1011711-23

Device Problems Deflation Problem (1149); Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045); Thrombosis (2100)

Event Date 12/17/2013

Event Type  Death  

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.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.The reported patient effects of thrombosis and death are known observed and potential patient effects as listed in the xience prime everolimus eluting coronary stent system instructions for use.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that using a femoral the artery access approach during a procedure of the left main bifurcation and calcified circumflex ostium a rota floppy wire was positioned and successful rotablation with a 1.25 mm burr in the left main to circumflex was performed; followed by 1.75 mm burr with partial success.A balance guide wire was advanced to the circumflex and balloon dilatation completed to the ostium and distal left main with a 2.5 and 3.0 mm balloons.The rota wire was removed and a second balance guide wire was advanced to the left anterior descending (lad).The 3.0 x 8 mm xience prime stent was deployed in the proximal lad without issue and well inflated at 16 atmosphere (atm).A second 4.0 x 23 mm xience prime stent was positioned from the ostium of the left main to overlap with the 3.0 x 8 mm xience prime and the 4.0 x 23 mm was quickly inflated to 18 atm; a waist was observed just distal to the bifurcation in the distal part of the stent.It was noted that the balloon remained partially inflated at the distal end and could not be deflated.Unsuccessful attempts to deflate the balloon were made using an indeflator for 20-30 seconds and then using a 15 ml syringe.The balloon was removed from the anatomy with a slight tug while partially inflated.After removal it was noted the distal end of the balloon was observed to be bunched; outside the anatomy the nurse was able to inflate the balloon, however, it could not be deflated.

Manufacturer Narrative

(b)(4).Event description continued: the stent was post dilated but the waist remained at the level of the bifurcation.Approximately 2 hours post stenting procedure while in the cath lab the patient began to experience cardiac arrest; a code was initiated, the patient was intubated, cardiopulmonary resuscitation (cpr) and multiple defibrillations, and medications/drugs used for intervention, however, the patient subsequently died; the cause of death was not provided.Additionally, it was noted that thrombosis was seen in the stent and extending into the circumflex and was exported.No additional information was provided.Concomitant products: guide wire: rota floppy; balance.The stent remains in the anatomy.The customer reported the stent delivery system (sds) was discarded.Investigation is not yet complete.A follow-up report will be submitted with all relevant information.

• Brand Name: XIENCE PRIME 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: 3569016
• MDR Text Key: 11419129
• Report Number: 2024168-2014-00234
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2015
• Device Catalogue Number: 1011711-23
• Device Lot Number: 3073141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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 Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 54