MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Catalog Number 4MAXC

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: 3005168196-2016-00552, 3005168196-2016-00553, 3005168196-2016-00554, 3005168196-2016-00555.The hospital disposed of the device.

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 6f 088 long sheath 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.

Manufacturer Narrative

Initial mfr.Report referenced the incorrect device: "neuron max 6f 088 long sheath" should have read "neuron max 8f 088 delivery catheter.".

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5617811
• MDR Text Key: 43981579
• Report Number: 3005168196-2016-00551
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 4MAXC
• Device Lot Number: F41762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• 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): Life Threatening; Other; Required Intervention
• Patient Age: 71 YR