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

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, a smart coil prolapsed from the wide neck aneurysm.The patient was given aspirin, integrin and antiplatelets infusion.The physician then placed an intracranial stent to prevent permanent impairment or damage.The event resolved on the same day, (b)(6) 2017.The wide neck aneurysm coil prolapse requiring stenting was adjudicated to be an adverse event with a probable 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: 7176668
• MDR Text Key: 96785713
• Report Number: 3005168196-2018-00094
• 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: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR