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

Catalog Number 1070250-48

Device Problem Defective Device (2588)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

The stent remains implanted in the 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 on (b)(6) 2021, a percutaneous coronary intervention (pci) was performed on the right coronary artery (rca) lesion.A 2.5x48mm xience xpedition stent was implanted in the distal right coronary artery (rca).Reportedly, there was no unusual resistance and no difficulty with implantation.Following and per imaging, the stent was observed only at 42.8mm in length.Reportedly, the stent had shortened during/after deployment.The procedure was completed with no adverse patient effects.No additional information was provided regarding this issue.

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 other similar incidents from this lot.It is possible that interactions with the anatomy and/or other devices resulted in shortening of the stent and/or user perception/inaccurate measuring under fluoroscopy may have resulted in difficulties visualizing the stent; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 11613934
• MDR Text Key: 245379638
• Report Number: 2024168-2021-02721
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Catalogue Number: 1070250-48
• Device Lot Number: 0022741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR