MAUDE Adverse Event Report: PENUMBRA, INC. APOLLO WAND; GWG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 12/01/2015

Event Type  Injury  

Event Description

During its post-market surveillance activities on 15-aug-2022, penumbra inc.Became aware of a journal article titled, "long-term functional independence after minimally invasive endoscopic intracerebral hemorrhage evacuation" (ali et al.2022).In this single center retrospective review, ninety patients underwent minimally invasive endoscopic evacuation (mis) to treat spontaneous intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis) or an apollo system between december 2015 and october 2018.Four patients had asymptomatic re-bleeding defined as a greater than or equal to five milliliter increase in hematoma volume between any two computed tomography (ct) scans up to thirty days post-procedure.Fifty-five patients experienced intraoperative bleeding.No additional information was provided.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

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.Hemorrhage is included as a possible complication in the instructions for use (ifu) for the apollo system the product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 1.3005168196-2022-00414.

• Brand Name: APOLLO WAND
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15397263
• MDR Text Key: 299665129
• Report Number: 3005168196-2022-00415
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1