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

Catalog Number	PSR3D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hematoma (1884); Hemorrhage, Subarachnoid (1893)
Date of Event	01/06/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).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 events were anticipated complications.The product was not returned for evaluation.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient underwent a thrombectomy procedure in the m1 of the middle cerebral artery (mca) on (b)(6) 2019 using a penumbra system 3d reperfusion catheter (psr3d).It was reported that the occlusion was treated with two passes of mechanical thrombectomy using the complete technique, resulting in a thrombolysis in cerebral infarction (tici) 2b recanalization with residual angular branch occlusion.Then two additional passes of mechanical thrombectomy using a non-penumbra stent retriever were made in conjunction with aspiration through a penumbra system jet 7 reperfusion catheter (jet7).This resulted in a tici score of 2c.The patient was then taken to the neuro-icu and was noted to be seizing with bilateral upper extremity involvement and vomiting.The patient was treated with emergent intubation and medication and then taken to have a computerized tomography (ct) scan.The ct scan revealed a large right hemisphere hematoma with a 1.6 cm midline shift, subarachnoid hemorrhage, intraventricular hemorrhage, and subfalcine herniation.Additional medication was administered; however, the patient¿s neurological exam continued to decline.The following morning on (b)(6) 2019 the patient did not have any brainstem reflexes.Family discussion was held between palliative, the hospital staff, the patient's husband and mother and decision to change code status to comfort care with terminal extubation was made.Upon family request, the patient was extubated and shortly after, expired.The patient's death was adjudicated to be a serious adverse event with a possible relationship to the psr3d and to the index procedure.
Event or Problem Description
Additional information received on (b)(6) 2019 indicated that the serious adverse event was unrelated to the psr3d and unrelated to the procedure.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra medical affairs associate on 30-nov-2019: describe event or problem.

• 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: 8333033
• Report Number: 3005168196-2019-00242
• Device Sequence Number: 1619587
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 01/14/2019
• 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 Catalogue Number: PSR3D
• 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: 01/14/2019
• Supplement Date Received by Manufacturer: 11/30/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: Death
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005