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 Myocardial Infarction (1969); Renal Failure (2041)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

B3: date of event estimated as 4/12/2018.D4: the udi is unknown due to the part/lot 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.A definitive cause for the reported patient effects of renal failure, myocardial infarction, and serious injury/illness/impairment and the relationship to the product, if any, cannot be determined.The reported patient effect of myocardial infarction is listed in the instruction for use as known adverse effects of intravascular imaging.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Literature attachment: article title - " optical coherence tomography¿guided or intravascular ultrasound¿guided percutaneous coronary intervention: the octivus randomized clinical trial.".

Event Description

The article discussed the octivus trial (optical coherence tomography versus intravascular ultrasound-guided percutaneous coronary intervention) which randomly assigned 2008 patients with significant coronary artery lesions undergoing pci in a 1:1 ratio to undergo either an oct-guided (c7-xr and optis) or ivus-guided pci.One incident of failure to cross occurred.At 1 year, primary end point events of myocardial infarction and contrast-induced nephropathy occurred in the oct group.The trial concluded that in patients with significant coronary artery lesions, oct-guided pci was non-inferior to ivus guided pci with respect to the incidence of a composite of death from cardiac causes, target vessel¿related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year.The selected study population and lower-than-expected event rates should be considered in interpreting the trial.Details are listed in the attached article, titled optical coherence tomography¿guided or intravascular ultrasound¿guided percutaneous coronary intervention: the octivus randomized clinical trial.No additional information was provided.

• 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: 18301810
• MDR Text Key: 330222558
• Report Number: 2024168-2023-13775
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK DRAGONFLY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/11/2023
• 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): Disability
• Patient Sex: Male