Stealth

Description of Event or Problem

It was reported that a Stealth 360 Peripheral Orbital Atherectomy Device (OAD) was used to prepare the femoral and iliac arteries for transfemoral transcatheter aortic valve replacement (TAVR) access. The treatment aimed to modify calcified lesions and facilitate the introduction and advancement of the valve delivery system. The femoral and iliac arteries were severely diseased, with extensive calcific burden throughout the intended access route. Despite the challenging anatomy, the OAD was successfully advanced to the target lesion and treatment was performed. A total of six treatments were completed: two at low speed, two at medium speed, and two at high speed. Following atherectomy, the operators assessed that additional plaque modification was required to achieve adequate vessel preparation. Angiographic images were taken but only with a non-compliant balloon (NC) balloon to check vessel compliance. The OAD was removed and the treatment was complemented with an intravascular lithotripsy (IVL) catheter to further modify the heavily calcified lesions within the femoral and iliac arteries and optimize the vascular access route for the subsequent TAVR procedure. Following vessel preparation, advancement of the TAVR introducer sheath and valve delivery system was attempted. Despite the prior lesion modification and vessel preparation, significant resistance was encountered during device advancement. The TAVR prosthesis was subsequently implanted successfully without further intraprocedural complications. Following valve deployment, substantial difficulty was encountered during withdrawal of the delivery system and introducer sheath. After device removal, the patient developed hypotension and hypovolemic shock. The patient¿s base rate was normal at 130 over 80. Angiographic assessment revealed an iliac artery dissection and/or perforation. Immediate endovascular management was initiated, including balloon inflation to control the vascular injury and implantation of multiple peripheral stents. Vascular surgery support was requested and incorporated into the management of the complication. The patient developed significant retroperitoneal hemorrhage secondary to the vascular complication, resulting in hemodynamic instability and cardiac arrest. Cardiopulmonary resuscitation was performed while endovascular treatment of the iliac and femoral arteries continued. Hemostasis was eventually achieved, and return of spontaneous circulation was obtained. The patient was transferred from the operating room, intubated and was under critical care management. Several hours after the procedure, the patient expired as a consequence of severe retroperitoneal bleeding and complications associated with the vascular injury and subsequent interventions. In the opinion of the physician the primary cause of expiration is vascular perforation and dissection of the iliac and femoral arteries during TAVR procedure, resulting in massive retroperitoneal hemorrhage, shock, cardiopulmonary arrest and subsequent expiration. In the opinion of the physician the OAD was intended to prepare the lesion to facilitate the TAVR delivery but due to insufficient vessel preparation, the delivery of the TAVR caused the perforation; the atherectomy treatment was not enough to smooth delivery of the TAVR device. The hypotension and hypovolemic shock were believed to be due to retroperitoneal hemorrhage caused by perforation of Iliac and femoral arteries. Per the opinion of the physician the plaque preparation made by OAD and the IVL device was insufficient for correct TAVR delivery; therefore, both contributed to the perforation caused by the TAVR device. There is no allegation of malfunction against the OAD - the insufficient vessel preparation for TAVR delivery was due to calcification and complex anatomy. There is no allegation of malfunction against the OAD - the insufficient vessel preparation for TAVR delivery was due to calcification and complex anatomy. No additional information was provided.

Additional Manufacturer Narrative

The device was not returned for analysis. Production record and Corrective and Preventative Actions (CAPA) reviews were performed and revealed no indication of a product quality issue. Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot-specific issue. Based on the information received, the investigation determined that the reported patient effects of cardiac arrest, death, blood loss, hospitalization, hypotension, perforation of vessels, vascular dissection and unexpected medical intervention appear to be related to operational context. In this case it is possible that the reported cardiac arrest, death, blood loss, hospitalization, hypotension, perforation of vessels, vascular dissection and unexpected medical intervention are a result of the patient¿s disease severity and/or use techniques employed; however, since the device was not returned this could not be confirmed. Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.