MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM SEPARATOR 054; NRY

Catalog Number PSS054

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893); Occlusion (1984); Paralysis (1997); Numbness (2415); Loss of consciousness (2418)

Event Date 03/19/2014

Event Type  Death  

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca, m1) using the penumbra system reperfusion catheter 054 and separator 054.Before the procedure, the patient was given intravenous tissue plasminogen (iv t-pa).During the procedure, a reperfusion catheter 054 was advanced to the m1 along with a chikai 0.014 inch through a roadmaster guiding catheter 90st 8f.Aspiration was conducted with a separator 054.An operation with a merci retriever done and aspiration was done again with the separator 054.The patient was then given 4000 units of heparin through injection.The consciousness level of the patient became decreased after the operation and the patient lost all the feeling on the left side.A computed tomography (ct) revealed extensive subarachnoid hemorrhage (sah) in the right mca area.Angiography showed not extravasation but occlusion in the right distal m1.The following morning, extensive infarct was observed in the right mca area through a ct; therefore, cranial decompression and ventricular drainage was conducted.Unfortunately, the patient expired approximately seven days later.Physician's comment: the events were related to the penumbra system, since extensive sah and occlusion in the right m1 were observed through ct right after the operation.It was likely that arterial dissection caused sah and acute occlusion, because they occurred simultaneously.The events were related to the penumbra system and the procedure.

Manufacturer Narrative

Conclusion: dissection and hemorrhage are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported event 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 mdr is associated with mdr 3005168196-2014-00326.Device was disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM SEPARATOR 054
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 3828195
• MDR Text Key: 17955446
• Report Number: 3005168196-2014-00327
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: PSS054
• Device Lot Number: F30685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2012
• 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): Death
• Patient Age: 24 YR
• Patient Weight: 41