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

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.

Manufacturer Narrative

Additional information was received which confirmed the patient's date of death was on (b)(6) 2020 instead of what was submitted in the initial report, on (b)(6) 2020.Csi id: (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.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 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 following 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.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10491267
• MDR Text Key: 205638125
• Report Number: 3004742232-2020-00270
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)220331(10)316389
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 316389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 81 YR