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 Problem Vascular Dissection (3160)

Event Date 07/30/2022

Event Type  Injury  

Event Description

It was reported through a case report an 18-year-old girl was hospitalized with progressive exertional chest pain for 1 month.She was previously diagnosed with kawasaki disease (kd) when she was 7 years old and was treated with intravenous immunoglobulin and acetylsalicylic acid.The patient was asymptomatic and received an annual echocardiogram follow-up.The echocardiogram showed that the lumen diameter of the proximal right coronary artery (rca) was 5.0 mm 1 month after kd diagnosis and was persistently less than 5.0 mm during follow-up.Four years before admission, the patient received coronary computed tomographic angiography (cta), indicating mild-to-moderate stenosis with mild dilation at the proximal rca.Repeated cta was performed just before admission, which revealed significant progression of the rca lesion.Invasive coronary angiography showed patent left coronary artery and subtotal occlusion at the proximal rca with mild coronary ectasia and suspected thrombus.After thrombectomy, optical coherence tomography (oct; dragonfly) revealed a complex coronary lesion with a heavy plaque burden (minimal lumen area 1.1 mm2), layered intima, focal calcification, macrophage accumulation, and microvessel.According to the online oct quantitative measurement, additional plaque modification was performed with a scoring balloon (nse 3.0 × 13 mm@14 atm, goodman, japan) and a non-compliance balloon (nc trek 3.5 × 15 mm@16atm, abbot, usa).Mild residual stenosis (approximately 10%) was found in the following coronary angiogram.Repeated oct pullback showed significant lumen enlargement (minimal lumen area 8.3 mm2) with intimal dissection.Dilation was subsequently performed, and the final angiogram showed timi grade 3 flow without significant stenosis and dissection.At the 1-year follow-up, the patient had no ischemic symptoms and had normal exercise capacity, and coronary magnetic resonance angiography revealed a patent coronary artery without significant restenosis.Details listed in the attached article, titled drug-coated balloon treatment for possible sequelae of kawasaki disease evaluated by multi-modalities.No additional information was provided.

Manufacturer Narrative

The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.Date of event estimated as 7/30/2022 publication date.The udi is unknown due to the part/lot number was not provided.Literature attachment.Article title: drug-coated balloon treatment for possible sequelae of kawasaki disease evaluated by multi-modalitiesna.

Manufacturer Narrative

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 effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of dissection is listed in the dragonfly optis instructions for use as known potential complications which may be encountered during the procedure.The unexpected medical intervention appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 15513388
• MDR Text Key: 300886043
• Report Number: 2024168-2022-10169
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 11/22/2022
• 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
• Patient Outcome(s): Required Intervention