MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070250-48

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xience xpedition 48 is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was to treat the ostial to mid left anterior descending (lad) coronary artery with 90-95% stenosis.Pre-dilatation was performed and then a 2.5x48 mm xience xpedition stent was implanted.Post-dilatation was performed and then it was noted that there was elongation of the xience xpedition stent of about 2-3 mm.Post-dilatation was performed again.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 identified no similar incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the media provided shows that there were multiple post dilatation inflations done post stent deployment.Upon initial deployment of the stent the stent balloon marker appears to be slightly proximal to the ostium of the treated vessel bifurcation.The post dilation process does not show any additional movement proximal into the vessel.Unless intended to be placed at this location this could be considered a ¿geographical miss¿ or a deployment slightly proximal than intended.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the positioning of the stent slightly proximal to the ostium during deployment caused the appearance of the reported stent elongation.This deployment could be what was reported to be ¿2-3 millimeters¿ of longitudinal elongation into the ostial vessel.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9592619
• MDR Text Key: 175095777
• Report Number: 2024168-2020-00699
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 1070250-48
• Device Lot Number: 9042541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER: APOLLO 3.0X15MM; BALLOON CATHETER: APOLLO 3.0X15MM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR