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

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

Patient Problems Intracranial Hemorrhage (1891); Ischemia Stroke (4418)

Event Date 08/16/2022

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.Small embolic infracts is included as a possible complication in the instructions for use (ifu) for the penumbra smart coil system, listed as embolic stroke and other cerebral ischemic events.Intracranial hemorrhage is included as a possible complication in the instructions for use (ifu) for the penumbra smart coil system.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

On (b)(6) 2022, the patient underwent a coil embolization procedure in the internal carotid artery (ica) and posterior communicating artery (pcom) using a penumbra smart coil (smart coil).On (b)(6) 2022, it was reported that the patient suffered from a word finding disorder and fine motor skills of the right fingers.A magnetic resonance imaging (mri) showed small embolic infarcts and a small hemorrhage infarct without space-occupying effect left.The patient was treated with logopedics and ergotherapy.On (b)(6) 2022, the patient was discharged with a modified rankin score (mrs) of 1.The small embolic infarcts and the small hemorrhage infarct without space-occupying effect were reported to be a non-serious adverse event with a possible relationship to the smart coil and a definite relationship to the index procedure.

• 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: 15442286
• MDR Text Key: 300120967
• Report Number: 3005168196-2022-00437
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/16/2022
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Female