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	09/16/2019
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 left m1 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).No procedural complications were reported.However, on (b)(6) 2019, the 24 hour follow-up form showed that the patient experienced an asymptomatic subarachnoid hemorrhage (sah) in the sylvian fissure on the left.The patient was treated with intravenous mannitol, nimodipine, unacid antibiotics, and was started on daily hemodialysis beginning on (b)(6) 2019.However, it was reported that the patient also passed away on (b)(6) 2019 due to a malignant cerebral edema.The asymptomatic subarachnoid hemorrhage was adjudicated to be a serious adverse event with a possible relationship to the psr3d and a probable relationship to the procedure.The malignant cerebral edema and subsequent expiration of the patient were adjudicated to be unrelated to the psr3d.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2019-01970.Section b.Box 5.Describe event or problem.
Event or Problem Description
On (b)(6) 2019, the patient underwent a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).No procedural complications were reported.However, on (b)(6) 2019, the 24 hour follow-up form showed that the patient experienced a symptomatic intracranial hemorrhage (ich) in the sylvian fissure on the left.The patient was treated with intravenous mannitol, nimodipin, unacid antibiotics, and was started on daily hemodialysis beginning on (b)(6) 2019.However, it was reported that the patient also passed away on (b)(6) 2019 due to a malignant cerebral edema.The ich was adjudicated to be a serious adverse event with a possible relationship to the psr3d and a probable relationship to the procedure.The malignant cerebral edema and subsequent expiration of the patient were adjudicated to be unrelated to the psr3d.

• 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: 9216111
• Report Number: 3005168196-2019-01970
• Device Sequence Number: 19378422
• 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,Followup
• Report Date (Section B): 09/23/2019
• 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?: 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
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/21/2019
• Supplement 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: 70 YR
• Date Report Sent to FDA: 01/01/2005