MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX SEPARATOR; NRY

Catalog Number 3MAXS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 04/03/2014

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using the penumbra system 5max ace reperfusion catheter, 3max reperfusion catheter, velocity catheter, 3max separator, and a penumbra separator flex 054.During the procedure, the devices worked at intended.However, post procedure; there was a re-occlusion of the right anterior cerebral artery.The physician completed two passes with a stent retriever device and multiple clots were removed.The event was moderate in severity with an uncertain relationship to the penumbra system and possible to the procedure.The physician explained that since the clot traveled to the new territory while opening up the original lesion area, it was difficult to determine what could have actually caused the movement of the clot.

Manufacturer Narrative

Conclusion: 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 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 3005168196-2014-00367, 00368, 00369 and 00371.Device was disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM 3MAX SEPARATOR
• 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: 3849002
• MDR Text Key: 4661348
• Report Number: 3005168196-2014-00370
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 3MAXS
• Device Lot Number: F39733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• 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): Required Intervention
• Patient Age: 67 YR