MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070275-48

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.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 the heavily tortuous, 90% stenosed, mildly calcified mid left anterior descending (lad) coronary artery.The 2.75x48 mm xience xpedition stent was advanced to the lesion with resistance noted with the anatomy and upon inflation the stent dislodged but did not deploy and was hanging in the lumen of the target lesion.Another 2.75x48 mm xience xpedition stent was used to be placed over the dislodged stent.There were no adverse patient sequela.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily tortuous, 90% stenosed and mildly calcified artery causing the reported difficulty to advance and subsequent dislodgement with the patient effect of device embedded and unexpected medical intervention.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION 48 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: 12562501
• MDR Text Key: 274275739
• Report Number: 2024168-2021-08805
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Catalogue Number: 1070275-48
• Device Lot Number: 0120141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention