MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

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

Patient Problem Vascular Dissection (3160)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Potential adverse events in the labeling with the neuron max system include, but are not limited to, vessel spasm, thrombosis, dissection or perforation, intracranial hemorrhage, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) and right internal carotid artery (ica) using a penumbra engine (engine), neuron max 6f 088 long sheath (neuron max), penumbra system jet 7 reperfusion catheter (jet7), penumbra system 3d revascularization device (psr3d), velocity delivery microcatheter (velocity), non-penumbra stent retriever.It was reported the patient has a past medical history of cardiovascular disease, diabetes, hyperlipidemia, hypertension, and was presented to outside facility with slurred speech, left facial droop and left arm drift.Patient received 89 milligrams of intravenous (iv) recombinant tissue plasminogen activator (rt-pa) while waiting for improvement.It was reported that the patient was last seen well and was not on any antiplatelet or anticoagulant medications.The patient was transferred to treating facility with a national institutes of health stroke scale (nihss) of 2 after the iv rt-pa at transferring facility, baseline modified rankin scale (mrs) 0.Neuron imaging (national center for competency testing (ncct), computed tomography angiography (cta), and computed tomographic perfusion (ctp)) was performed identifying the location of the primary occlusion in the right m1 mca and tandem occlusion at the right ica with modified treatment in cerebral infarction (mtici) score 0 and alberta stroke program early ct score (aspects) 9.During the procedure, the physician placed the neuron max to the face of the clot via femoral access.Heparin was then administered for flushing system, four milligrams of intraarterial (ia) rt-pa, and vasodilator were also used.The physician made the first pass using the neuron max, jet7, psr3d resulting in mtici score of 0.The psr3d was then removed and a second pass was made using the same jet7, velocity, neuron max and a stent retriever; however, it was unsuccessful resulting in mtici score of 0.A third pass was attempted using the same jet7, stent retriever, velocity and neuron max but was still unsuccessful with mtici of 0.Subsequently, while crossing the cervical ica proximal occlusion to perform another pass, a non-occlusive dissection of the ica occurred and was reported as a non-serious adverse event not requiring any treatment.The physician made the final pass using the same jet7, stent retriever, velocity and neuron max resulting in a final mtici of 2a in the m1 segment of the mca and in the right ica.Th procedure was complete at this point and patient was transferred to a dedicated stroke unit.In the stroke unit on day one post-procedure, nihss was 24.Initial nihss after admission to outside facility was not reported.Nihss was 2 as it was assessed on admission to the treating hospital following iv rt-pa.It was confirmed that nihss of 24 was not related to the adverse event.There was no intracerebral hemorrhage (ich) and/or subarachnoid hemorrhage (sah) observed on ncct take on day one post-procedure.A single antiplatelet medication was started.Day seven post-procedure, patients nihss was 25 and mrs 5.On day 15 post-procedure, patient was discharged to a skilled nursing facility on a single antiplatelet medication.On day 29 post-procedure, patient was at home with outpatient care support with mrs of 4 and remained unchanged on day 78 post-procedure when patient exited the study.On 19-(b)(6) 2021, the intracranial vessel dissection was adjudicated to be unrelated to the index stroke, psr3d, jet7, and iv rt-pa; however, it is related to the index procedure and neuron max.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 11532312
• MDR Text Key: 243014800
• Report Number: 3005168196-2021-00545
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 74 YR