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

Model Number DBEC-125

Device Problems Unintended System Motion (1430); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/23/2024

Event Type  Death  

Manufacturer Narrative

Additional information has been requested but not yet received.The investigation is ongoing.Csi id: (b)(4).

Event Description

Following treatment and balloon rupture of the shockwave device, the diamondback 360 coronary orbital atherectomy device (oad) was advanced and used for treatment.The patient expired.

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a dissection, slow/no flow and chest pain are potential adverse event that may occur and/or require intervention with use of the system.H6 health effect - suggested clinical code.4581: slow/no flow.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

[procedure details prior to orbital atherectomy treatment].Following an emergency room visit on (b)(6) 2024 for symptoms consistent with exertional angina with acute exacerbation on the last 72 hours and recurring chest discomfort, the patient was admitted.A complex high risk percutaneous coronary intervention (pci) with mechanical circulatory support procedure was performed on (b)(6) 2024.The treatment area was a moderately calcified, 70% stenosed distal left main extending to the bifurcation with heavily calcified nodular, calcific 70% stenosis of the ostial left anterior descending artery (lad), and moderate to severe 60% ostial stenosis of the left circumflex.Access was obtained through the left femoral artery using a micropuncture needle via the modified seldinger technique under ultrasound guidance.A 5f sheath and j-wire were advanced to the descending thoracic aorta under fluoroscopic guidance.A 5f diagnostic catheter was then advanced and a wire exchanged was performed for a lunderquist guidewire to straighten the extremity tortuous aorta and facilitate delivery of the impella.After the insertion of the impella, the 5f sheath placed across the lad was exchanged for a 7f destination sheath and advanced into the descending thoracic aorta.A 7f guide catheter was successfully placed in the ostium of left main coronary artery.After guiding angiograms were required, a non-csi/abbott guidewire was attempted to be advanced into the lad but was unsuccessful but was later successfully advanced to the left circumflex.An intravascular lithotripsy (ivus) catheter was advanced over the guide wire across the left main circumflex to the proximal vessel and a pullback assessment was performed using chroma flow imaging.The proximal vessel was measured at 3.0mm with moderate, 180-degree calcific plaque noted at the ostium of the left circumflex extending into the distal left main.The mid left main was measured at 5.5mm, the distal segment was measured around 5.0mm at the bifurcation.An asahi guidewire was then advanced into the left anterior descending artery and with the non-csi/abbott guidewire position maintained across the left circumflex.Ivus imaging was performed across the distal left main extending into the lad.Ivus was unable to be advanced beyond the ostial segment of the left anterior descending artery with 207-degree calcium noted at the bend.A decision was made to forego planned atherectomy across the left anterior descending artery and proceed with shockwave of the mid followed by ostial segment.The shockwave was successfully advanced to the severe mid segment stenosis.During shockwave treatment, the balloon ruptured and was removed.Angiogram was acquired and no evidence of dissection or perforation was observed.The non-csi/abbott guidewire was removed, and a non-csi/abbott balloon was advanced into the distal lad.[procedure details when orbital atherectomy treatment begins] a non-csi/abbott guide wire was exchanged for a viperwire advance guide wire.A diamondback 360 coronary orbital atherectomy device (oad) was advanced to the distal left main.Glideassist was activated to successfully reach the proximal bend in the lad.The oad was spun on low speed and during the second spin, the oad was observed to have jumped forward across the mid segment bend and became stuck.Glideassist was activated but could not free the oad.The patient complained of chest discomfort and at the same time there was a decline in hemodynamics/blood pressure readings.Angiogram was checked and showed no evidence of dissection or perforation in the vessel, though there was limited visualization of the distal lad.An attempt was made to advance the non-csi/abbott guidewire along the oad in the lad but was unsuccessful.The oad driveshaft was cut.A 7f guide liner guide extension catheter was successfully advanced to the proximal lad.The oad was freed and removed without difficulty.However, while attempting to keep the guide extension catheter in position in the proximal lad, and advance the non-csi/abbott guidewire back into the vessel, the guide extension catheter moved back into the left main.At this point, the patient had ongoing hemodynamic collapse and multiple vasopressors as well as atropine.Angiogram showed no significant flow across the circumflex and the presence of a large dissection in the proximal lad.A non-csi/abbott guidewire was advanced, and angioplasty of the left circumflex was performed, and flow was restored.Following multiple unsuccessful attempts to rewire the lad lumen with three different guidewires, a non-csi/abbott guidewire was advanced and appeared to have been in lumen proximally but due to significant overlap due to tortuosity of the vessel, the guidewire could not be positioned across the mid to distal segment.It was at this time that a perforation was observed in the mid segment of the vessel which had not been earlier observed.The patient status at this point was ongoing hemodynamics collapse with the impella, which had to be place on p2 despite aggressive iv fluid resuscitation and emergent blood transfusion.The patient was also intubated for airway protection after initial bipap.Despite the guidewire position a balloon was placed in in the proximal and later in the mid segment of the vessel and angioplasty was performed to treat the distal perforation.The patient's hemodynamics worsened and collapsed.At this time the decision was made to forego any further attempts at revascularization.All wire and catheters were removed.Impella was removed.The patient expired.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18746819
• MDR Text Key: 335865767
• Report Number: 3004742232-2024-00109
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250831(10)502647-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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 Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 502647-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2023
• 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