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

Model Number	PND6F070956M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Edema (1820)
Date of Event	06/07/2019
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.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
On (b)(6) 2019, the patient successfully underwent a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).It was noted that the patient presented to the hospital with a baseline national institutes of health stroke scale (nihss) score of 17.There was no reported complication during the procedure.On (b)(6) 2019, a follow up magnetic resonance imaging (mri) scan was performed, which revealed cerebral edema with a baseline nihss of 18.The patient was treated with medication.As of (b)(6) 2019, the event is still ongoing and the patient is still hospitalized.This event was adjudicated to be serious adverse event with a possible relationship to the psr3d and the index procedure.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra representative on 02/25/2020.1.Section b.Box 5.Describe event or problem.
Event or Problem Description
Based on additional information received on 25-feb-2020, there was no alleged deficiency related to any penumbra device.The adverse event was determined to be unrelated to any penumbra device and, therefore, this is not a valid complaint.

• 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: 8809381
• Report Number: 3005168196-2019-01410
• Device Sequence Number: 16224987
• Product Code: NRY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162901
• 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): 06/20/2019
• 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 Model Number: PND6F070956M
• 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: 06/20/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 03/05/2020
• 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: 70 YR
• Date Report Sent to FDA: 01/01/2005