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

Catalog Number 1070300-38

Device Problems Kinked (1339); Failure to Advance (2524); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported material deformation and the reported kink were able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.Additionally, the distal tip entry was flared and torn.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported that the procedure was to treat a heavily tortuous, heavily calcified, 97% stenosis in a segmental lesion in the distal circumflex (cx).There was an unsuccessful attempt to cross the lesion due to an angulation in the proximal portion of the cx.Upon stent removal the distal stent struts were noted to be damaged and the shaft was noted to be kinked.Two smaller stents were implanted through overlap for treatment of the distal cx.There was no resistance noted upon advancement or removal of the device.There were no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.The returned device evaluation revealed that the tip was torn.

• 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 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: 6752650
• MDR Text Key: 81411743
• Report Number: 2024168-2017-06274
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2018
• Device Catalogue Number: 1070300-38
• Device Lot Number: 5031341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Age: 63 YR
• Patient Weight: 88