MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); PERIPHERAL ATHERECTOMY DEVICE (GUIDEWIRE)

Model Number VPR-GW-FLEX14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/20/2022

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 material inpsection report for this guidewire 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.It should be noted that use of the device in the mesenteric artery is an off-label application.The instructions for use manual states, "the diamondback 360® peripheral orbital atherectomy system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy." (b)(4).

Event Description

A diamondback peripheral orbital atherectomy device (oad) was used for treatment of the superior mesenteric artery (sma).Right groin access was obtained, and a 6fr guide catheter was used.The vessel was primary wired with a.014 coronary guidewire (non-csi wire).The ostium and proximal segment were severely calcified.Following wire exchange, multiple low, medium, and high treatments were performed with excellent result.The oad was stopped in the proximal section, and the physician attempted removal of the oad.Resistance was encountered in removing the device as the sma curved back 180 degrees in the proximal segment.The physician used more force than typical to remove the wire and oad, but the force was not extreme.At that time, it was noted that a portion of the wire remained in the patient.The remaining portion was approximately 15-20cm.Angioplasty was applied to the treatment area.An unsuccessful attempt was made to snare the remaining wire.The fragment was unable to be retrieved via snare and was ultimately stented against the vessel wall.Stenting of the artery post oas was planned prior to procedure.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE (GUIDEWIRE)
• 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13834317
• MDR Text Key: 288289171
• Report Number: 3004742232-2022-00068
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)230731(10)388061-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2022

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: 07/31/2023
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 388061-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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): Other
• Patient Sex: Female