• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number P-2ST-SO200-145
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/02/2020
Event Type  Injury  
Manufacturer Narrative
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 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. Additional information was requested from the site, but no response was received. If additional information is received, a supplemental report will be submitted. (b)(4).
 
Event Description
A csi orbital atherectomy device was selected for treatment of lesions in the superficial femoral artery (sfa) and the peroneal artery. The sfa was heavily calcified, with a diameter of 7-8mm and no tortuosity. There was a two vessel runoff below the knee through a moderately diseased peroneal artery. Treatment passes on low and medium speeds were performed in the sfa, and imaging showed no issues. Balloon angioplasty with a drug coated balloon followed. After the balloon angioplasty, slow flow was observed in the sfa along with no flow. Nitroglycerin was administered, and the vessel was flushed. Slow flow was observed. Aspiration below the knee was performed, and a large amount of solid, calcified embolic material was aspirated. It was determined that the embolization occurred during orbital atherectomy, the embolized material were larger than 2 microns, and that the embolization caused the no and slow flow. After aspiration, flow in the sfa had improved, however, flow issues were still observed in the peroneal artery. The case was stopped, and a consult was performed. It was determined through review of pre-procedure imaging that a bypass was not an option. A limb amputation was performed. The patient remained hospitalized and was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEALTH ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer Contact
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key10762126
MDR Text Key214150649
Report Number3004742232-2020-00342
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10850000491479
UDI-Public(01)10850000491479(17)220228(10)312730
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2022
Device Model NumberP-2ST-SO200-145
Device Lot Number312730
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2020
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: 10/30/2020 Patient Sequence Number: 1
-
-