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

Catalog Number 1070275-38

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 90% stenosed, moderately tortuous de novo lesion in the left anterior descending (lad) coronary artery.After pre-dilatation with an unspecified balloon dilatation catheter (bdc), a 2.75x38mm xience xpedition was deployed at 10 atmospheres (atm).After post dilatation was performed with a 2.75x12mm non-abbott bdc at 16 atm, a longitudinal elongation of the 2.75x38mm xience xpedition stent was noted, of 2-3 mm towards ostial lad.The procedure was successfully completed with the xience xpedition 2.75x38mm.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

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.The images provided do not clearly show any stent elongation.What is observable is that during the final post dilatation inflations of the balloon, the guiding catheter advanced forward into the ostium of the vessel towards the proximal stent edge while the balloon apparently deflated, strongly implying that the balloon was interacting with the stent struts, possibly ¿snagging¿ on them.This interaction, combined with the advancement of the guiding catheter, could have led to some proximal stent elongation, which was reported but not observed on the provided media.The investigation was unable to determine a conclusive cause for the reported stretched stent; however, factors that could contribute to a stretched stent include, but are not limited to, interaction with accessory devices, interaction with anatomy and product placement.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: removed conclusion code 4307.

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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the implanted stent interacted with the balloon catheter during post dilation causing the reported stretched stent.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: 9565150
• MDR Text Key: 177985752
• Report Number: 2024168-2020-00461
• 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,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2022
• Device Catalogue Number: 1070275-38
• Device Lot Number: 9033041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER: APOLLO 2.75X12 MM