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

Catalog Number 1074250-38

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

It was reported that during device preparation, the protective sheath and stylet were unable to be removed.It was noted that the distal end of the stylet had perforated through the orange part of the delivery catheter.The device was set aside and not used.There was no patient involvement.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported difficulty to remove the sheath and stylet were able to be confirmed.There was no tear in the shaft.The reported torn material was unable to be confirmed.Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint database revealed no other similar incidents reported for difficult to remove protective sheath/stylet or for torn material from this lot.Based on the information reviewed, there is no indication of a product deficiency.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.

• 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: 4102914
• MDR Text Key: 4696271
• Report Number: 2024168-2014-06058
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2016
• Device Catalogue Number: 1074250-38
• Device Lot Number: 4051941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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