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

Model Number DBP-EX-200SOL145

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 10/14/2021

Event Type  Death  

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.Additional event information has been requested.If received, a supplemental report will be submitted.The device history record for the reported oad was unable to be reviewed, as the lot number was not provided.Csi id: (b)(4).

Event Description

A diamondback peripheral exchangeable orbital atherectomy device (oad) was used to treat a heavily calcified, 95% stenosed lesion in the left common iliac.During a treatment pass on medium speed, the patient became hypotensive.Imaging was performed and extravasation was noted and determined to be a perforation.The oad was removed and an attempt was made to insert an additional guide wire.A covered stent was inserted but was unable to control the bleeding.As the bleeding was unable to be controlled from an endovascular approach, the physician performed a cut down procedure to perform further intervention.The bleeding was unable to be controlled and the patient expired.

Manufacturer Narrative

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 prior to distribution.Csi id: (b)(4).

Event Description

A diamondback peripheral exchangeable orbital atherectomy device (oad) was used to treat a heavily calcified, 95% stenosed lesion in the left common iliac.During a treatment pass on medium speed, the patient became hypotensive.Imaging was performed and extravasation was noted and determined to be a perforation.The oad was removed and attempt was made to insert an additional guide wire.Balloon angioplasty was attempted but the balloon ruptured.A covered stent was inserted but did not cover the full perforation and extravasation remained.As the bleeding was unable to be controlled from an endovascular approach, the physician performed a cut down to perform further intervention.The patient expired due to blood loss.

• 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; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 12816518
• MDR Text Key: 280787210
• Report Number: 3004742232-2021-00374
• Device Sequence Number: 1
• Product Code: MCW
• 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,Followup
• Report Date: 12/06/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: DBP-EX-200SOL145
• Device Lot Number: 346405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Sex: Female