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

Catalog Number 1070300-33

Device Problems Inflation Problem (1310); Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

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 performed to treat a moderately calcified, mildly tortuous left anterior descending (lad) artery.The 3.0x33mm xience xpedition balloon inflated distal to proximal and the physician found that to be improper.Additionally, the stent went 2-3mm into the ostium of the left main coronary artery.There was no stretching or any other damage to the stent.The stent remains in the target lesion.There were no adverse patient effects and no 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 a clinical specialist.The reviewer concluded that the cine images did not provide evidence confirming that the 3.0x33 mm xience xpedition des moved upon deployment.The images provided did confirm the filling of the balloon upon deployment; however, it did not look abnormal and the stent was deployed successfully.No product malfunction was identified.In this case, it is possible that the reported inflation problem (distal to proximal balloon inflation) may have been due to patient anatomical morphology (moderately calcified, mildly tortuous lesion), causing the stent to move slightly during deployment which may have contributed to the reported unintended system motion/difficult to deploy.Factors that may contribute to inflation issues include, but are not limited to, patient anatomical morphology, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Unintended system motion/difficulty deploying the stent may be attributed to several factors including, but are not limited to, stent placement, patient anatomical morphology (calcification, tortuosity), inflation technique during use of the product or under-sizing of the vessel.However, based on the information provided and without the product to examine, a conclusive cause for the reported difficulties 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 DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11402039
• MDR Text Key: 239099619
• Report Number: 2024168-2021-01640
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Catalogue Number: 1070300-33
• Device Lot Number: 0021441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1