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

Model Number DBEC-125

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

Patient Problems Chest Pain (1776); Death (1802); Myocardial Infarction (1969)

Event Date 12/05/2018

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.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.Csi id# (b)(4).

Event Description

Following a coronary atherectomy procedure using a csi diamondback orbital atherectomy device (oad), it was reported that the patient expired.The target lesion was located in the left anterior descending artery (lad) near a previously placed stent.The lesion was treated with three passes of the oad on low speed.Following the third pass, decreased flow was noted in a diagonal branch near the lesion.Balloon angioplasty was performed in the lad and a stent was placed as part of the original procedure plan.An attempt was made to perform balloon angioplasty in the diagonal branch; however, the balloon would not advance past the previously placed lad stent.A balloon pump was inserted and the patient was observed.The patient presented with chest pain, which resolved.The evening following the procedure, the patient again presented with chest pain and a diagnostic cardiac catheterization was performed.The catheterization revealed that flow was present in the lad and the diagonal branch, and the patient was discharged.It was reported to csi that five days following the procedure the patient presented with an acute myocardial infarction.A cardiac catheterization was performed and found that the lad was completely occluded at the location of the previously placed stent.The patient entered cardiac arrest and expired.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY 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: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 8200240
• MDR Text Key: 131526235
• Report Number: 3004742232-2018-00386
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)200831(10)238608
• 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: 12/27/2018

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: 08/31/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 238608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• 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 Age: 58 YR