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

Model Number 5MAXACE068KIT

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 08/21/2019

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 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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68). During the procedure, the physician advanced a neuron max 6f 088 long sheath (neuron max) in the left common carotid artery over a non-penumbra catheter, followed by visualization of the internal carotid artery (ica) with discontinuity at its origin. Next, probing with a non-penumbra guidewire and a non-penumbra cross, subsequent visualization of the left ica showed the left m1 occlusion. Thereafter, the physician performed a percutaneous transluminal angioplasty (pta), placed a stent device, then performed another pta. Subsequently, the physician administered 510 micrograms of aggrastat in the left ica then inserted the neuron max. The physician then aspirated the thrombus in the carotid-t using the ace68. The thrombus could thus be directly removed, with evidence of occlusion at the trifurcation of the mca. Therefore, the physician again used the ace68 and performed aspiration of the distal left m1 segment of the mca. A check angiography was then performed and revealed that the thrombi in the left hemispheric vessel was completely removed. Visualization of the stent and the extracranial course of the ica showed minimal dissection of the left ica; however, there was no hemodynamic effect and therefore, anticoagulation was not required. No hemorrhage was seen and the neuron max and ace68 were removed from the patient. The following day, (b)(6) 2019, the patient had neurological deterioration which led to a computed tomography scan (ct scan) that showed intraparenchymal hemorrhage in the left temporoparietal region measuring approximately 30 x 19 centimeters surrounded by a rim of hypodense edema. Additionally, there was a mild and partial compression of the left lateral ventricle with no midline shift. There was hemorrhage in the subarachnoid region, especially in the left sulci and basal cisterns. The left sulci are partially effaced with no significant change in the ventricular width and no midline shift. The patient is stable with national institutes of health stroke scale (nihss) of 6 and a modified ranking scale (mrs) of 4. On (b)(6) 2019, a ct scan indicated that the extracranial vessel dissection and intracranial hemorrhage are still ongoing. The extracranial vessel dissection was reported to be non-serious adverse event with a probable relationship to the ace68 and index procedure. The intracranial hemorrhage was reported to be a serious adverse event with a probable relationship to the ace68 and index procedure.

• 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: 9111400
• MDR Text Key: 159963188
• Report Number: 3005168196-2019-01800
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/21/2022
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F89199
• 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
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/24/2019 Patient Sequence Number: 1