MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE

Model Number DBEC-125

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Ventricular Tachycardia (2132); Loss of consciousness (2418); Cardiac Perforation (2513)

Event Date 03/07/2014

Event Type  Death  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a perforation occurred and the patient later expired.The target lesion, located in the proximal-to-mid circumflex artery, was severely calcified, 70% stenotic and 22mm in length.The circumflex artery had a reference vessel diameter of 3.0mm-3.5mm.The physician used a 6f introducer sheath to access the lesion.The physician first completed one run at low speed using a csi orbital atherectomy device (oad).He then performed a contrast injection and no complications were noted.He then performed a second run at low speed and then a third run at high speed.The total spin time for the three runs was 56 seconds.After treating the target lesion, the physician advanced the device distally and treated the lesions in the distal circumflex artery.After the final run, he performed a contrast injection and noted a perforation in the distal circumflex artery.The physician then attempted to resolve the perforation using multiple balloon angioplasty inflations, but was unsuccessful.He then delivered a multi-link mini vision stent to the perforation site, but was unable to resolve the perforation.The patient heart rate began to increase and he decided to place an intra-aortic balloon pump.The patient then went into ventricular tachycardia which required two separate shock treatments, during which the patient was also intubated.Six more stents (one of which was a drug-eluting stent) were delivered and multiple balloon inflations were performed.The physician then delivered an impella device which remained in the patient for around 90 minutes, after which it was removed.The patient was transferred to the surgical intensive care unit (sicu) unresponsive and intubated.The patient expired the following morning at 5:08am.

Manufacturer Narrative

The oad was returned without the original guide wire.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft revealed a kink in the driveshaft 49.8cm distal to the distal edge of the strain relief when the control knob is in the full forward position.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.Examination of the crown and driveshaft in this area did not reveal any damage that would have contributed to the tissue accumulation.The outside diameter of the crown and crown location on the driveshaft were measured and met the drawing specifications.The driveshaft and saline sheaths were also measured and met their respective drawing specifications.An in-house 0.012" test wire was loaded through the device with minimal resistance met at the driveshaft kink site.When tested, the led's on the handle assembly illuminated as expected and the device spun at low and at high speed with no abnormalities observed.At the conclusion of the failure analysis investigation the root cause of the perforation and subsequent death could not be determined.The returned device functioned as intended and did not exhibit any damage that would have led to the difficulties experienced during the procedure.Analysis revealed a kink in the driveshaft, although a guide wire passed through this location with little resistance and the device spun with no issue.Additionally, the case details did not mention any issues that would be related to a kinked driveshaft.Therefore, the driveshaft kink likely occurred after the procedure and did not contribute to the event.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).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 3720061
• MDR Text Key: 18574255
• Report Number: 3004742232-2014-00016
• Device Sequence Number: 1
• Product Code: MCX
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2014

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: Physician
• Device Expiration Date: 02/28/2016
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 93955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• 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: 82 YR