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

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

Patient Problems Stroke/CVA (1770); Convulsion/Seizure (4406)

Event Date 12/21/2021

Event Type  Injury  

Manufacturer Narrative

Potential adverse events in the labeling with the smart coil system include, but are not limited to, incomplete aneurysm occlusion, emboli, embolic stroke, and other cerebral ischemic events, including death.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

On (b)(6) 2021, the patient underwent a coil embolization procedure in the v4 segment of the posterior circulation using penumbra smart coils (smart coil).On (b)(6) 2021, the patient showed increased aphasia with a national institutes of health stroke scale (nihss) of 5.However, the computed tomography angiography (cta) and magnetic resonance imaging (mri) showed no change with all symptoms resolved.On (b)(6) 2021, the patient returned to the emergency department (ed) due to sudden-onset confusion with a nihss of 2 for complete hemianopsia.The cta was negative, and the mri showed three punctate acute infarcts in the right cerebellar hemisphere.It was also reported that the seizure was presumed to be secondary to the punctate stroke.This event was considered resolved as of (b)(6) 2021.The punctate stroke and seizure were reported to be serious adverse events with a probable relationship to the index procedure and a possible relationship to the smart coil system.

Manufacturer Narrative

Please note that the following section was updated based on the additional information provided by the clinical investigator on 20-jan-22: 1.Section b.Box 5.Describe event or problem.H3 other text : placeholder.

Event Description

On (b)(6) 2021, the patient underwent a coil embolization procedure in the v4 segment of the posterior circulation using penumbra smart coils (smart coil).On (b)(6) 2021, the patient returned to the emergency department (ed) due to sudden-onset confusion with a national institutes of health stroke scale (nihss) of 2 for complete hemianopsia.The computed tomography angiography (cta) was negative, and the magnetic resonance imaging (mri) showed three punctate acute infarcts in the right cerebellar hemisphere.The patient was admitted to the neuro floor.On (b)(6) 2021, the patient showed increased aphasia with a nihss of 5.However, the cta and mri showed no change with all symptoms resolved.It was also reported that the seizure was presumed to be secondary to the punctate stroke.This event was considered resolved as of (b)(6) 2021.The punctate stroke and seizure were reported to be serious adverse events with a probable relationship to the index procedure and a possible 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: 13287511
• MDR Text Key: 286583366
• Report Number: 3005168196-2022-00016
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 01/20/2022
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Female