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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.
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Type of DeviceDQY
Manufacturer (Section D)
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
MDR Report Key9111400
MDR Text Key159963188
Report Number3005168196-2019-01800
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
Number of Events Reported1
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 Received09/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/21/2022
Device Model Number5MAXACE068KIT
Device Catalogue Number5MAXACE068KIT
Device Lot NumberF89199
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received02/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2019
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