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

Catalog Number 1011707-33

Device Problems Difficult or Delayed Positioning (1157); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a 90% stenosed proximal left anterior descending (lad) coronary artery with no tortuosity and no calcification.Pre-dilatation was performed using a 2.00x15mm nc traveler balloon dilatation catheter (bdc).A 2.5x33mm xience prime rx stent delivery system (sds) was advanced to the lesion without resistance.During sds inflation, it was noted that the indeflator lost pressure.The initial indeflator was replaced, and the replacement indeflator also lost pressure.The balloon did not inflate properly and the stent did not fully expand due to a hole/leakage located on the shaft approximately 20 centimeters from the balloon.It was further reported that the sds had not been prepped outside the patient prior to use.Subsequently, a bdc was advanced to the lesion and successfully expanded the stent.There was no adverse patient effect and no reported clinically significant delay in the procedure.Subsequently, a bdc was advanced to the lesion and successfully expanded the stent.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported shaft leak; however, the reported difficulty to deploy appears to be related to circumstances of the procedure as it is likely the shaft leak prevented the device balloon from fully inflating causing the reported difficulty to deploy.Additionally, the device was prepped inside the anatomy prior to the reported difficulties.It should be noted that the xience prime everolimus eluting coronary stent system, instructions for use (ifu) lists that the preparation is to be performed prior delivery procedure.In this case, it is unknown if the ifu deviation related contributed to the reported leak and difficulty to deploy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: XIENCE PRIME LL 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7587862
• MDR Text Key: 110642515
• Report Number: 2024168-2018-04366
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2020
• Device Catalogue Number: 1011707-33
• Device Lot Number: 7050841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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): Required Intervention