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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-MICRO
Device Problems Entrapment of Device (1212); Material Separation (1562)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Renal Failure (2041); Vascular System (Circulation), Impaired (2572)
Event Date 08/06/2020
Event Type  Death  
Manufacturer Narrative
The oad was returned for analysis. Visual examination revealed that the distal crown and tip bushing section were not returned. The driveshaft was severely elongated and exhibited two fractures. Scanning electron microscopy of the driveshaft fractures identified the presence of torsional ductile overload, consistent with the driveshaft having been pulled to fracture. At the conclusion of the device analysis investigation, the report that the device was stuck in the vessel and that the vessel shut down due to oad removal could not be confirmed through analysis. The driveshaft fracture was confirmed. It was hypothesized that the driveshaft fractures were due to high tensile forces experienced during removal from the patient's body, however the exact root cause was undetermined. The device history record for this oad lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The device met material, assembly, and quality control requirements. Patient is over 80 years, exact age is unknown. This report is related to the viperwire guide wire reported under report number 3004742232-2020-00269. (b)(4).
 
Event Description
The stealth peripheral orbital atherectomy device was selected for treatment of a severely calcified lesion in the peroneal artery. During the first treatment pass the oad became stuck in the mid peroneal artery. Troubleshooting attempts including pushing and pulling on the oad, and insertion of a buddy wire and balloon to remove the device were made but were unsuccessful. The oad was then pulled hard and was able to be removed, however the crown on the driveshaft had fractured and remained stuck in the vessel. Imaging revealed the peroneal vessel had shut down due to removal of the oad. The patient was transferred to the hospital for a four-hour bypass surgery to resolve the issue and the crown fragment was removed. The patient was fine on (b)(6) 2020 during a follow-up visit, however on (b)(6) 2020 the patient presented with renal failure, despite having no history of renal failure. The patient was hospitalized and expired on the same day, due to renal failure. Per the opinion of the physician, the length of the two procedures combined with the vessel shut down and amount of contrast likely used throughout the procedures led to renal failure.
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer Contact
brittany leider
1225 old highway 8 nw
saint paul, mn 
2591600
MDR Report Key10491267
MDR Text Key205638125
Report Number3004742232-2020-00270
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model NumberPRD-SC30-MICRO
Device Catalogue Number7-10059-01
Device Lot Number316389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/03/2020 Patient Sequence Number: 1
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