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

Model Number	PNML6F088804
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Vascular Dissection (3160)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max).During the procedure, after placing the neuron max in the target vessel, the physician noticed there was poor aspiration while using a penumbra system jet 7 reperfusion catheter (jet7) and a non-penumbra microcatheter.Subsequently, the physician found the distal end of the neuron max to be kinked and, therefore, it was removed.The procedure was completed using a new neuron max with the same jet7 and microcatheter.It was reported that the patient experienced vasospasm in the ica and was treated with 100 microgram of intra-arterial nitroglycerin; however, the vasospasm is unrelated to any penumbra devices used in the index procedure.
Additional Manufacturer Narrative
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 was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max).During the procedure, after placing the neuron max in the target vessel, the physician noticed there was poor aspiration while using a penumbra system jet 7 reperfusion catheter (jet7) and a non-penumbra microcatheter.Subsequently, the physician found the distal end of the neuron max to be kinked and, therefore, it was removed.The procedure was completed using a new neuron max with the same jet7 and microcatheter.It was reported that the patient experienced vasospasm in the ica and was treated with 100 microgram of intra-arterial nitroglycerin; however, the vasospasm is unrelated to any penumbra devices used in the index procedure.Subsequently, the physician performed an angiogram that revealed a small filling thrombus in the proximal petrous portion of the ica.While making the final pass, the physician advanced the jet7 to the level of the filling of thrombus and additional aspiration was performed.Another angiogram was performed and revealed a clearing of filling defect but a residual nonflow limiting dissection was identified.It was also reported at, that modified treatment in cerebral infarction (mtici) 3 was achieved and no further intervention was conducted.The procedure was completed at this point and the patient was transferred to dedicated stroke unit.In the stroke unit on day one post-procedure, national institutes of health stroke scale (nihss) was down to 7 versus 35 at admission.Dual antiplatelet medication was started.On day three post-procedure, patient was discharged to a skilled nursing facility on dual antiplatelet medication.Patients nihss was further down to 3.On day 38 post-procedure, patient was at home without any outpatient care support with modified rankin scale (mrs) of 1 and remained unchanged on day 83 post-procedure when patient exited the study.On 19-feb-2019, the intracranial vessel dissection was adjudicated to be a non-serious adverse event related to the neuron max and index procedure.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9099004
• Report Number: 3005168196-2019-01795
• Device Sequence Number: 16800053
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019
• Report Date (Section F): 01/01/2005

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: PNML6F088804
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F87219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005