MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK CORONARY ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

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

Patient Problems Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 07/21/2020

Event Type  Death  

Manufacturer Narrative

Device analysis conclusion: the oad was received for analysis.Visual examination did not reveal any damage that would have contributed to the reported event.When functionally tested, the oad operated as intended.Review of the device data log did not reveal any issue that would have contributed to the reported complaint.As the guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the reported complaint.The root cause of the reported slow flow, dissection, and patient death events could not be confirmed.The physician's opinion is that the oad caused a dissection which was exacerbated by the post dilatation balloon.In the opinion of the physician, the patient's death was due to the inability to tamponade the perforation after a stent came off of the angioplasty balloon.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 diamondback coronary orbital atherectomy device (oad) was selected for treatment of three lesions in the left anterior descending artery (lad) via radial access.The lesions from the proximal to the mid section of the lad were heavily calcified.Intravenous ultrasound (ivus) imaging was attempted prior to oa, but the ivus catheter could not be advanced into the most proximal lesion.Several treatments were administered with the oad on low speed.Following the final treatment, slow flow was observed in the distal lad.The oad was removed.There was no visible extravasation, though the possibility of dissection was considered.The distal lesion was post dilated.The patient then experienced a drop in blood pressure and complained of chest pain, and a perforation was identified.A balloon was used to tamponade the perforation, and covered stents were delivered.An issue was encountered during stent deployment which caused difficulty in delivering additional devices to the area for mitigation of the perforation.An impella was implanted, but the patient expired.

• Brand Name: DIAMONDBACK CORONARY ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10428555
• MDR Text Key: 203621725
• Report Number: 3004742232-2020-00244
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220331(10)321025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2020

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: 03/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 321025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2020
• 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: 84 YR