MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE; NRY

Model Number	PSR3D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	09/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra system include, but are not limited to, intracranial hemorrhage, hematoma or hemorrhage at the site, inability to completely remove thrombus, ischemia, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d), and a non-penumbra stent retriever device (preset).It was reported that the patient presented to the hospital with a left hemispherical syndrome with motor-related aphasia and a right-sided latent hemiparesis.No procedural complications were reported and a thrombolysis in cerebral infarction (tici) grade 3 recanalization was achieved.On (b)(6) 2019, a computed tomography (ct) of the neurocranium performed at 09:08 am revealed a hemorrhage into the left infarction area and a subarachnoid hemorrhage (sah) in the left hemisphere and blood levels in the posterior ventricular posterior horns.The physician then administered aspirin with clexane to the patient.A subsequent ct of the neurocranium performed later the same day at 09:06 pm showed that there was no increase in the left frontal bleeding and left hemisphere sah.When transferred to the normal ward, the patient was awake, cooperative, calm, 4/5 hemiparesis on the right, non-fluid aphasia with normal understanding, sinus rhythm (sr) / cardiopulmonary stable, mobilized for walking with therapists for a few meters.The national institutes of health stroke scale (nihss) score was 4 and the modified rankin scale (mrs) score was 4.After moving to the normal neurological ward, diagnosis and therapy continued as well as the physiotherapy, occupational therapy and speech therapy exercises.The initial symptoms were regressive.However, there is aphasia and slight gait uncertainty.On (b)(6) 2019, the patient still presented an aphasia but was neurologically stable and was discharged home.The intracranial hemorrhage was reported to be a serious adverse event related to the psr3d and the index procedure.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9944932
• Report Number: 3005168196-2020-00538
• Device Sequence Number: 3881478
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K190464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: PSR3D
• Device Catalogue Number: PSR3D
• Device Lot Number: F91667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/09/2020
• 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: Required Intervention
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005