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

Catalog Number 1070300-28

Device Problems Unintended System Motion (1430); Difficult to Advance (2920)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Intimal Dissection (1333)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the mid right coronary artery with mild tortuosity and 88% stenosis.A 3.00 x 28 mm xience xpedition stent delivery system (sds) was advanced against resistance from the anatomy.On deployment of the stent, the sds jumped [moved] resulting in a dissection.Due to the movement of the sds, the stent was not properly apposed to the vessel wall.An additional 3.00 x 28 mm xience xpedition stent was deployed to embed the poorly apposed stent in the vessel wall and treat the dissection.The patient was reported to be recovering well post procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The reported patient effect of a dissection is listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined a conclusive cause for the reported difficult to deploy (wall apposition) cannot be determined; however, the reported physical resistance and subsequent treatment appear to be related to the circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 8171922
• MDR Text Key: 130612719
• Report Number: 2024168-2018-09776
• 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,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Catalogue Number: 1070300-28
• Device Lot Number: 8080841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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 Outcome(s): Required Intervention