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

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

Patient Problem Occlusion (1984)

Event Date 03/06/2018

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.Re-occlusion (distal embolization) is a known and anticipated complication 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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.It is unknown why the device has not been returned for evaluation.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).It was reported that there was an occlusion of the frontal branch of the middle cerebral artery, which arose from the neck of the aneurysm.The physician retracted and removed the smart coil, and performed additional treatment to address this device related adverse event, and the event is considered resolved.The occlusion was adjudicated to be a device related adverse event with a definite relationship to the smart coil system.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7494933
• MDR Text Key: 107631795
• Report Number: 3005168196-2018-00947
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• 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
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 48 YR