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

Catalog Number 1070350-12

Device Problems Difficult To Position (1467); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: estimated date of event.The location of the reported device was not provided; however, when information is received the investigation will be completed.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a 3.50 x 12mm xience xpedition stent delivery system (sds) did not advance on a 0.014 guide wire.The device failed to cross the lesion.After the sds was removed from the guiding catheter, it was noted that the stent implant was partially separated from the balloon in the proximal section.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Date of event changed from (b)(6) 2017 to (b)(6) 2017.Device status changed from unk to returned.The device was returned for analysis.The reported difficult to position was able to be confirmed.The reported unstable stent was unable to be confirmed however there was inner member bunching.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 manufacture, design or labeling.

Event Description

Subsequent to the initially filed mdr, the procedure was to treat a non-tortuous, mildly calcified ostium coronary artery that was 70% stenosed.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Date received by manufacturer is 1/10/2018.

• 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: 7034619
• MDR Text Key: 92856895
• Report Number: 2024168-2017-08998
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2019
• Device Catalogue Number: 1070350-12
• Device Lot Number: 6020441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 01/11/2017; 01/18/2018
• Supplement Dates FDA Received: 01/12/2018; 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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
• Patient Age: 86 YR
• Patient Weight: 60