MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 03/01/2016

Event Type  Injury  

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 neuron max system include, but are not limited to, hematoma or hemorrhage at puncture site, vessel spasm, thrombosis, dissection, or perforation, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2020-01185, 3005168196-2020-01186, and 3005168196-2020-01187.

Event Description

Penumbra inc.Became aware on 15-jul-2020 during its post-market surveillance activities of a journal article titled, ¿aspiration thrombectomy as the first-line treatment of m2 occlusions." (harsany et al., 2020).It was reported that 82 patients with acute ischemic stroke and isolated m2 segment occlusions were treated in a cerebrovascular stroke center using the neuron max 6f 088 long sheath (neuron max) and either the penumbra system 4max reperfusion catheter (4maxc), the penumbra system ace 60 reperfusion catheter (ace60), or the penumbra system ace 64 reperfusion catheter (ace64).All data was collected from a single center between march 2016 and june 2019.Among all patients, five experienced symptomatic intracranial hemorrhage (sich).However, there is no allegation within the article that a malfunction of the penumbra system occurred.The relationship between the penumbra devices and the sich was not specified.It was not reported whether any action was taken to treat the cases of sich.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.Therefore, this report addresses all adverse events within this literature source.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• 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: 10405253
• MDR Text Key: 203121874
• Report Number: 3005168196-2020-01184
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• Reporter Country Code: LO
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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: 07/15/2020
• 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
• Patient Outcome(s): Other