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

Model Number	PSR3D-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/11/2019
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, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse event were anticipated complications.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2019-02038.
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 3d revascularization device (psr3d) and a penumbra system jet 7 reperfusion catheter (jet7) from a penumbra system jet 7 kit.During the procedure, the physician advanced the jet7 along with a non-penumbra microcatheter and a microwire through a neuron max 6f 088 long sheath (neuron max) toward the left m1.The physician then advanced the microcatheter and microwire through the clot into the distal m1.The microwire was then removed and the microcatheter was left in place.After gentle angiography was performed demonstrating antegrade flow, the physician advanced the psr3d to the distal end of the microcatheter.The physician then withdrew the microcatheter, deploying the psr3d beyond the clot in the distal m1.The psr3d was then carefully withdrawn and the first pass was completed.A second pass was then completed in a similar manner using the same devices.It was reported that no procedural complications occurred.Following the intervention, the patient was given amiodarone to control for prior underlying conditions as well as mannitol to reduce the mass effect of cerebral edema.On (b)(6) 2019, serial non-contrast computerized tomography (ncct) imaging of the brain revealed that the patient had experienced an intracranial hemorrhage.Further ncct imaging was performed in order to track the progression of the hemorrhage and showed that the patient¿s condition was stable throughout and without changes.It was reported on (b)(6) 2019 that the intracranial hemorrhage resolved.The patient was transferred to a rehabilitation facility on (b)(6) 2019.It was adjudicated that the intracranial hemorrhage was a serious adverse event with a possible relationship to the psr3d and to the jet7, and a possible relationship to the index procedure.
Event or Problem Description
Additional information received on (b)(6) 2020 indicated that the serious adverse event of intracranial hemorrhage was adjudicated to be unrelated to the psr3d and jet7.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra medical affairs associate on (b)(6) 2020: this report is associated with mfr report number: 3005168196-2019-02038.

• 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: 9269797
• Report Number: 3005168196-2019-02037
• Device Sequence Number: 2272371
• Product Code: NRY
• UDI-Device Identifier: 00815948020900
• UDI-Public: 00815948020900
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: PSR3D-C
• Device Catalogue Number: PSR3D
• Device Lot Number: F90675
• 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: 10/04/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 11/02/2019
• Supplement Report FDA Received Date: 03/17/2020
• 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: Other
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005