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

Catalog Number 1074225-23

Device Problems Inflation Problem (1310); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a concentric lesion in the distal right coronary artery with no tortuosity, mild calcification and 25% stenosis.The vessel diameter was 2.5 mm and the lesion length was 23 mm.After pre-dilatation was performed with a non-abbott balloon catheter, a 2.25x23 mm rx xience xpedition sv stent delivery system (sds) was advanced without resistance and pressurized for the first time, but the balloon did not inflate at all.The sds was pressurized a second time and the balloon did inflate at a low pressure and the stent implant was able to be deployed; however, the stent was not fully apposed to the vessel wall.Reportedly, there was no difficulty deflating the sds balloon and the sds was withdrawn from the patient anatomy without resistance.A 2.25x8 mm non-abbott balloon catheter was advanced and inflated to 12 atmospheres to further expand and appose the stent to the vessel wall.Post procedure the sds was pressurized outside of the anatomy and it was confirmed that the balloon could not hold pressure as a hole/tear was noted proximal to the balloon.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: sion blue, guide catheter: hyperion 6f sal1.0.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and device was pressurized when fluid was seen leaking from the guide wire exit notch.A review of the lot history record (lhr) was conducted and found no non-conforming reports for this lot.Additionally, the a review of the complaint handling database found no other incidents related to this issue for this lot.Although a product issue was identified, it appears to be an isolated incident.Based on the related records review, review of the electronic lhr for this lot and the actual complaint rate, there is no indication that the larger population of product is affected by this issue.Additionally, there is no evidence to suggest that the product issue affects inventory or distributed product.

• 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: 4189399
• MDR Text Key: 5101914
• Report Number: 2024168-2014-06851
• 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: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2016
• Device Catalogue Number: 1074225-23
• Device Lot Number: 4032441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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 CATHETER: HYPERION6F SAL1.0
• Patient Outcome(s): Required Intervention