MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM REPERFUSION CATHETER; CATHETER, THROMBUS RETRIEVER

Model Number	ICRC071137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/24/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices were discarded after use and therefore not available for return and investigation.There were no device deficiencies reported related to the zoom 88 or zoom 71.Based on the information provided and without case images, the exact cause for the recurrent stroke is unknown.It was reported that the patient had achieved complete reperfusion after the first thrombectomy procedure.The relationship with the zoom devices to the recurrent stroke could not be established.It is unclear if the recurrent stroke was caused by the zoom devices, the stent retriever, or the hypercoagulable condition the patient was found to later have.The manufacturing records for the zoom devices were reviewed and demonstrated that the product met all the design and manufacturing specifications.The following mfr # were submitted: mfr # 3013590708-2024-00022 for zoom 88; mfr # for zoom 71.
Event or Problem Description
A 67-year-old male patient was being treated for an occlusion at the left m1 segment.A zoom 88 access catheter and a third-party insert catheter were introduced into the left common carotid artery (cca) as a system.A roadmap angiogram was completed of the cca to visualize the carotid bifurcation.A diagnostic catheter was used to select the internal carotid artery (ica) over a glidewire.The zoom 88 was then advanced and parked at the ica cavernous.During the first and second passes, a third-party microcatheter and microwire were advanced through a zoom 71 aspiration catheter as a system into the zoom 88.The zoom 71 was advanced to the face of the clot and aspiration was applied.The zoom 71 catheter was removed under continuous aspiration from the patient.A contrast run showed the thrombus was not aspirated.During the third pass, a different third-party microcatheter and microwire were advanced through the zoom 88 past the m1 occlusion.The microwire was removed from the microcatheter and replaced with a stent retriever.The stent retriever was advanced and allowed to set in the clot for 5 minutes.The stent retriever was removed; however, the thrombus was not captured within the stent retriever.For the fourth pass, the same third-party microcatheter and microwire used in the third pass were again advanced through the zoom 88 past the m1 occlusion.The microwire was removed from the microcatheter and replaced with the same stent retriever.The stent retriever was deployed and again set in the clot for 5 minutes.The stent retriever was removed, and the thrombus was captured within the stent retriever.An angiogram was performed and recanalization of the left m1 distribution was achieved with a tici 3 score.No device issues were reported.One week post initial procedure, the patient presented with an altered mental status.A computed tomography angiography (cta) showed a new occlusion at the left m2 segment.The patient received a second mechanical intervention, and the recurrent stroke was resolved with tici 3 reperfusion.No procedure or device information was provided.Three weeks after the second thrombectomy procedure, the patient was discharged home.One month after discharge, it was noted that the patient developed a hypercoagulable condition, which led to his passing approximately ten days later.Per the physician, the cause of death was hypercoagulable condition.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC.; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell; campbell, CA 95008-6609
• MDR Report Key: 19779103
• Report Number: 3014590708-2024-00023
• Device Sequence Number: 20878300
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K211476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2219901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARISTOTLE 18 MICROWIRE; ASAHI CHIKAI GUIDE WIRE; MARKSMAN MICROCATHETER; SOLITAIRE STENT RETRIEVER; TREVO TRAK21 MICROCATHETER; ZOOM 71
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White