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

Model Number PRD-SC30-200

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

Patient Problems Pain (1994); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 03/13/2020

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.(b)(4).

Event Description

A stealth peripheral orbital atherectomy device (oad) was used in the right superficial femoral artery (sfa).The target lesion was 2.5cm long, and was treated with six (6) passes on low speed and two (2) passes on medium speed.After the second pass on medium speed, the patient experienced pain above the knee.A vessel spasm was observed on imaging below the treatment area.Prostaglandin was administered, and the physician waited two minutes before continuing.Two (2) additional treatment passes on medium speed were performed with the oad.Balloon angioplasty was performed.Angiography of the treatment area showed a good treatment result; however, imaging below the knee showed closure of all runoff vessels.An embolization aspiration system was used, the vessel was opened, and the patient was heparinized.Two days after the procedure, the patient had recovered, and had circulation to the foot.

• Brand Name: STEALTH 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9940781
• MDR Text Key: 188002527
• Report Number: 3004742232-2020-00114
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491110
• UDI-Public: (01)10850000491110(17)220430(10)268244
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PRD-SC30-200
• Device Lot Number: 268244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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: 69 YR