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 12/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 of the reported lot 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.

Event Description

It was reported that the procedure was to treat a de novo, 100% stenosed lesion in the moderately tortuous ostial right coronary artery (rca) to the mid rca.Pre-dilatation was performed with multiple balloon dilatation catheters and the 2.75x38 mm xience xpedition stent was deployed.Post-dilatation was performed and it was noted that there was elongation of the xience xpedition stent about 4-5 mm into the ostial rca.Post-dilatation of this segment was performed.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Additional information: a cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded, on examination of the images, it¿s possible that there was some stent elongation, but it¿s difficult to be conclusive.It also appears that the stent has migrated proximally in the later images.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the balloon catheter used to post dilate interacted with the implanted stent during post dilation causing the reported stretched stent and stent migration seen during cine review.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: 9577141
• MDR Text Key: 174703304
• Report Number: 2024168-2020-00556
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• 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: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR