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

Catalog Number UNK XIENCE

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

The dragonfly device referenced is filed under a separate medwatch report number.The udi number is not known as the part and lot number were not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident review for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during a procedure to treat a plaque rupture in the mid right coronary artery.A pre-percutaneous coronary intervention (pci) run was performed using a dragonfly catheter without issue.An unspecified xience stent was implanted and the post pci run was performed without issue; however, during removal of the dragonfly catheter it got caught with the implanted stent causing the stent to become crushed.The dragonfly catheter was able to be withdrawn with resistance from the patient anatomy.The physician attempted to re-open the stent without success and ended up implanting an additional unspecified xience stent to crush the damaged stent to the vessel wall.There was no adverse patient effect and no reported clinically significant delay in the procedure.While performing review of the optical coherence tomography (oct) runs after the procedure it was noted that the guide wire and dragonfly catheter were not coaxial and too far apart.No additional information was provided.

• Brand Name: XIENCE 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: 13895653
• MDR Text Key: 288597068
• Report Number: 2024168-2022-03134
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATHETER: DRAGONFLY
• Patient Outcome(s): Required Intervention