MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN DRAGONFLY; DIAGNOSTIC INTRAVASCULAR CATHETER

Catalog Number UNK DRAGONFLY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Tachycardia (2095); Ventricular Fibrillation (2130); Perforation of Vessels (2135); Cardiogenic Shock (2262); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

B3: date of event estimated.D4: the udi number is not known as the catalogue number was not provided.The device was not returned for analysis.A review of the lot history record could not be performed as the device was not returned for evaluation and the lot number was not provided.Additionally, a review of the complaint history could not be completed as the device was not returned and the lot number was not provided.The reported patient effects of dissection, perforation, and thrombus are listed in the dragonfly optis instructions for use as known potential complications which may be encountered during the procedure.In this case, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.A definitive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effects of renal failure, tachycardia, ventricular fibrillation, cardiogenic shock, hemorrhage/blood loss/bleeding, stroke/cva, thrombosis/thrombus, perforation of vessels, and vascular dissection 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.Literature attachment: e-180100article.Literature attachment: appendix e-180100.The additional patient effect of death reported in the article is captured under a separate medwatch report.

Event Description

It was reported patients with complex bifurcation lesions had optical coherence tomography (oct)-guided percutaneous coronary intervention (pci) or angiography-guided pci.The primary end point was a composite of major adverse cardiac events (mace), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.The xience everolimus-eluting stent was prespecified for implantation.The article identified xience drug-eluting stents that may be related to stent malposition, patient deaths, myocardial infarction, ischemia, stent thrombosis, target vessel revascularization, re-hospitalization.The article's supplemental appendix mentioned ventricular tachycardia (vt), ventricular fibrillation (vf), cardiogenic shock, major bleeding, stroke, vessel occlusion, perforation, and dissection as procedure related complications; coronary artery bypass graft revascularization was also noted.The supplemental appendix also listed the following procedural related complications during oct guided pci, vt/vf, cardiogenic shock, major bleeding, stroke, vessel occlusion, perforation, dissection and death.Contrast-associated acute kidney injury without an oct/dragonfly malfunction was mentioned during oct guided pci.The article concluded; oct-guided pci had a lower incidence of mace at 2 years than angiography-guided pci.Details are listed in the attached article, titled ¿oct or angiography guidance for pci in complex bifurcation lesions.".

• Brand Name: UNKNOWN DRAGONFLY
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17864991
• MDR Text Key: 324848657
• Report Number: 2024168-2023-10796
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK DRAGONFLY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• 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
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male