FDA Adverse Event Death Summary report: N

PENUMBRA SYSTEM SEPARATOR 041

MDR report key: 1983841 · Received February 4, 2011

Report

Report Number: 3005168196-2011-00052
Event Type: Death
Date Received: February 4, 2011
Date of Event: January 21, 2010
Manufacturer: PENUMBRA, INC.
Product Code: NRY
PMA / PMN Number: K072718
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

VESSEL DISSECTION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

Description of Event or Problem · 1

DURING TREATMENT FOR A STROKE, THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE (ICH). DURING THE TREATMENT PROCEDURE WITH THE PENUMBRA SYSTEM, THE LEFT MCA WAS DISSECTED. A NON-CONTRAST CT THE FOLLOWING MORNING SHOWED A LARGE DEGREE OF INTRAPARENCHYMAL HEMORRHAGE WITHIN THE LEFT FRONTAL PARIETAL LOBE, WITH EXTENSIVE SUBARACHNOID HEMORRHAGE NOTED OVER THE HEMISPHERES BILATERALLY, WITHIN THE INTERHEMISPHERIC FISSURE AND FILLING THE BASILAR CISTERNS AND FORTH VENTRICLE. BLOOD LAYERS WITHIN THE OCCIPITAL HORNS BILATERALLY, AND THERE IS SIGNIFICANT MASS EFFECT WITH EFFACEMENT OF THE LEFT LATERAL VENTRICLE AND APPROXIMATELY 1 CM LEFT-TO-RIGHT MIDLINE SHIFT. THE PHYSICIAN RATED THIS SERIOUS ADVERSE EVENT AS DEFINITELY RELATED TO THE STUDY DEVICE. THE (B)(6) WAS 13 AT ADMISSION AND WAS 31 POST-PROCEDURE, AND BECAME COMATOSE. THREE DAYS LATER, THE PATIENT EXPIRED, THE ULTIMATE CAUSE OF DEATH WAS NOTED AS "BRAIN DEATH". THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00096 WHICH PERTAINS TO PENUMBRA SYSTEM REPERFUSION CATHETER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PENUMBRA SYSTEM SEPARATOR 041	PERCUTANEOUS CATHETER	NRY	PENUMBRA, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Death