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

Catalog Number 1070350-18

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

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

Event Date 02/15/2021

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 identified no other similar incidents from this lot.Reportedly, the device was not prepared outside of the patient anatomy.It should be noted that the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states: note: while introducing the delivery system into the vessel, do not induce negative pressure on the delivery system.This may cause dislodgement of the stent from the balloon.It is undetermined if the deviation of the ifu caused/contributed to the reported difficulties.Factors that can contribute to difficulties removing the protective sheath include, but are not limited to, damage during manufacturing, damage to the protective sheath, damage to the stylet, damage to the inner lumen, mishandling, stent damage, or oversized balloon and stent due to partial inflation or protective sheath removal technique.Additionally, factors that may contribute to inflation/deflation issues include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Furthermore, stent dislodgement can be influenced by many factors, including, but not limited to; improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with the lesion, accessory devices, and/or previously implanted stents.It is possible that inadvertent mishandling during sheath removal resulted in the reported difficult to remove-sheath and resulted in compromising the inflation/deflation lumen; thus, resulting in the reported inflation problem and the reported deflation problem.Interaction with the heavily tortuous anatomy resulted in the reported stent dislodgement.However as the device was not returned for analysis the investigation determined a conclusive cause for the reported difficulties cannot be determined.

Event Description

It was reported that during device preparation, the sheath was difficult to remove, and the device was not prepared outside of the patient anatomy.During the heavily tortuous proximal left anterior descending coronary artery intervention, during stent deployment, the stent balloon inflated, but was not symmetrical, causing the stent to dislodge and implant in the ostium of the artery.Balloon deflation was slow, but the balloon eventually deflated, and the stent delivery system was removed.Another xience xpedition stent was implanted over the first implanted stent without issue.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11509521
• MDR Text Key: 240551479
• Report Number: 2024168-2021-02123
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Catalogue Number: 1070350-18
• Device Lot Number: 0022741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention