MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

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

Patient Problem Hemorrhage, Subarachnoid (1893)

Event Date 05/22/2018

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.Hemorrhage 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 thrombus formation was an anticipated procedural complication.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.The device was implanted in the patient.

Event Description

The patient underwent a coil embolization procedure on (b)(6) 2018 using penumbra smart coils (smart coils).After the procedure, one small subarachnoid hemorrhage was found on the computed tomography scan (ct scan).As of (b)(6) 2018, this event is ongoing.This subarachnoid hemorrhage was adjudicated to be an adverse event with a probable relationship to the smart coil system, and a probable relationship to the procedure.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7642108
• MDR Text Key: 112474393
• Report Number: 3005168196-2018-01257
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other