MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070300-48

Device Problems Deflation Problem (1149); Leak/Splash (1354); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the mildly tortuous proximal left anterior descending (lad) coronary artery.A 3.00 x 48 mm xience xpedition stent delivery system (sds) was selected for the procedure.Resistance was felt during removal of the sds from the dispenser hoop/coil, there was no resistance felt during removal of the mandrel or protective sheath and there were no issues noted during prep (air aspiration).The sds was advanced to the lesion and the stent implant was successfully deployed at a pressure of 11 atmospheres.Following the deployment of the stent implant the sds balloon would not fully deflate.There was a little resistance felt while removing the sds with the partially deflated balloon from the anatomy.After removal from the anatomy a leak was found mid shaft of the sds.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties removing the device from the dispenser coil, deflation issues, or leak.The difficulties removing the device from the anatomy appear to be related to circumstances of the procedure as it is likely that an interaction of the partially deflated balloon with the anatomy caused the resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE XPEDITION 48 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: 6187841
• MDR Text Key: 63111025
• Report Number: 2024168-2016-09027
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2019
• Device Catalogue Number: 1070300-48
• Device Lot Number: 6063041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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