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

Catalog Number 1070250-18

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/19/2020

Event Type  Injury  

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 to treat a lesion in the heavily calcified, moderately tortuous, 95% stenosed de novo, left anterior descending artery (lad).A 2.5x18mm xience xpedition drug eluting stent (des) was advanced but was unable to cross the lesion.Upon removal of the stent system, the stent dislodged in the left main artery (lm).A wire was advanced and pushed the dislodged stent into the left circumflex (lcx) artery where a xience stent was implanted to embed the dislodged stent.There was no adverse patient sequela and 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 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 that resistance was met with the heavily calcified, moderately tortuous, 95% stenosed anatomy resulting in the reported failure to advance.Upon removal interaction and/or manipulation of the device resulted in the reported stent dislodgement.The treatment appears to be related to the operational context of the procedure as a wire was advanced and pushed the dislodged stent into the left circumflex artery where a xience stent was implanted to embed the dislodged stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 11007647
• MDR Text Key: 221487889
• Report Number: 2024168-2020-10462
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Catalogue Number: 1070250-18
• Device Lot Number: 9020441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HT BMW USL II 0.014" 190CM, 1009664 LOT 9071671.; MINI TREK 1.2 X 12, 1012268-12 LOT 90913G1.; MINI TREK 2.0 X 25, 1012270-25 LOT 90722G1.; TREK 2.25 X 15, 1012271-15 LOT 90724G1.; TREK 2.5 X 12, 1012272-12 LOT 90909G1.; XIENCE XPEDITION 3.5 X 28, 1070350-28 LOT 9042641.; HT BMW USL II 0.014" 190CM, 1009664 LOT 9071671.; MINI TREK 1.2 X 12, 1012268-12 LOT 90913G1.; MINI TREK 2.0 X 25, 1012270-25 LOT 90722G1.; TREK 2.25 X 15, 1012271-15 LOT 90724G1.; TREK 2.5 X 12, 1012272-12 LOT 90909G1.; XIENCE XPEDITION 3.5 X 28, 1070350-28 LOT 9042641.
• Patient Outcome(s): Required Intervention