MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that thrombosis/thrombus is a potential adverse event that may occur and/or require intervention with use of the system.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for the reported oad could not be reviewed as the lot number was not provided.Csi id: (b)(4).

Event Description

A literature review from the european heart journal by imamura et al."unusual optical coherence tomography findings resembling sea anemone tentacles after orbital atherectomy for nodular calcification lesions in a haemodialysis patient: a case report", observed on optical coherence tomography imaging (oct) granular and filamentous structures.A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a heavily calcified and stenosed left anterior descending artery (lad).The patient was a haemodialysis patient with nodular calcifications (nc).The oad was spun for three low speed treatments and once on high speed retrograde for treatment.Following oad treatment, oct showed newly emerged granular and filamentous structures that resembled thrombus and appeared to be platelet/fibrin thrombi, which closely resembled a calcified nodule (cn).The structures appeared to be continuous from the debulked nc lesion proximal to the target site.The presence of the filamentous structures did not appear to affect the patient, the electrocardiogram was unchanged, there was no evidence of slow flow or distal embolization.A non-csi/abbott balloon was advanced and post dilatation, extensive medial dissection occurred, and the structures appeared to have migrated distally.Stent placement covering the structures was performed.No complications occurred and oct showed the structures secured to the outside of the stents.The patient was stable but did experience in-stent restenosis four months post procedure.Mayuko imamura, kei yunoki, katsunori miyahara, and takefumi oka.Unusual optical coherence tomography findings resembling sea anemone tentacles after orbital atherectomy for nodular calcification lesions in a haemodialysis patient: a case report.European heart journal - case reports (2024) 8, 1-6 https://doi.Org/10.1093/ehjcr/ytae095.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19096164
• MDR Text Key: 340023425
• Report Number: 3004742232-2024-00156
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 58 KG