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Catalog Number VEL160STR-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Infarction, Cerebral (1771); Reocclusion (1985)
Event Date 06/27/2014
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. Distal embolization (re-occlusion), is a known and anticipated complication with these types of procedures and is noted in the device labeling. Therefore, it was determined that the reported re-occlusion with multi-vessel infarction was an anticipated procedural complication. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report numbers: 3005168196-2016-00551, 3005168196-2016-00552, 3005168196-2016-00554, 3005168196-2016-00555.

Event Description

The patient underwent a thrombectomy procedure using a penumbra system 4max reperfusion catheter, a penumbra system 5max ace reperfusion catheter, a velocity delivery microcatheter, a neuron max 8f 088 delivery catheter and a neuron 6f select catheter and complete recanalization of the target vessel was achieved. However, after the procedure the patient went into atrial fibrillation (a-fib) and was immediately given 25 mg of iv cardizem before becoming hypotensive. On postoperative day 1 ((b)(6) 2014), a magnetic resonance imaging (mri) was performed as a routine follow-up. Upon return, there was abnormal extension in the patient's right upper extremity (rue) and diminished corneal. The mri scans demonstrated large areas of acute/subacute infarction in the left cerebral hemisphere, predominantly in the middle cerebral artery (mca) distribution, but also within the anterior cerebral artery (aca) and posterior cerebral artery (pca) distributions. A magnetic resonance angiogram (mra) demonstrated occlusion of the left internal carotid artery (ica) and mca. Later, on the same day ((b)(6) 2014), a non-contrast computerized tomography (ncct) was performed and showed subacute left mca infarct and no acute hemorrhage. A re-occlusion of the distal ica including the pca either from new embolus to local thrombosis from vessel injury was noted as well. On postoperative day 9 ((b)(6) 2014), a ncct of the patient's head was performed and showed subacute infarction in the left hemispheric temporal lobe, insula frontal lobe, parietal lobe and basal ganglia with mild mass effect on the left lateral ventricle. There was no significant change. In addition, there was dense left proximal mca and distal ica, which was unchanged. On postoperative day 20 ((b)(6) 2014), the patient was more sleepy and mildly lethargic. Repeated ct did not show any worsening of stroke or any bleeding, but that the edema and mass effect resolved. The patient had evolving multifocal left hemispheric infarct consistent with the cerebrovascular accident (cva) for which the patient was initially being treated for. On the day of discharge ((b)(6) 2014), the patient was back to her baseline from the day before and was discharged to a rehabilitation facility in stable condition. On (b)(6) 2014, the patient was seen again and showed neurological improvement from the prior visit. The reported re-occlusion with multi-vessel infarction was reviewed and adjudicated by the committee to be a serious adverse event that was possibly related to the penumbra system and the procedure, but unrelated to the index stroke.

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Type of DeviceDQY
Manufacturer (Section D)
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda, CA 94502
MDR Report Key5618234
MDR Text Key43978840
Report Number3005168196-2016-00553
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date02/28/2017
Device Catalogue NumberVEL160STR-A
Device LOT NumberF41488
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/14/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 04/28/2016 Patient Sequence Number: 1