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

Catalog Number 1070300-23

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat a lesion in the left anterior descending artery, a 3.0x23 mm rx xience xpedition stent delivery system (sds) was advanced without resistance and during inflation, leakage at the shaft was observed as there was a potential tear in the shaft.The sds was simply withdrawn from the patient anatomy without issue.Reportedly, the 3.0x23 mm rx xience xpedition sds was prepped per the instructions for use without any issues noted.Another xience xpedition stent was used to treat the target lesion without issue.There was no adverse patient effect and no 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.The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the returned device analysis identified a leak in the area of the guide wire exit notch.A search of the complaint handling database was performed and no other incidents were identified from this lot for leaking issues.A search of the lot history record for this specific lot indicated no related non-conformance records.Based on an expanded investigation, there is a potential product deficiency.There is no indication that a wider population of product is affected; further assessment of this issue per site operating procedures was performed.These devices will continue to be monitored.

• 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: 4215195
• MDR Text Key: 5038513
• Report Number: 2024168-2014-07112
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 1070300-23
• Device Lot Number: 4052641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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