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

Model Number 400SMTSTD0408

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/17/2021

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.Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, aneurysm rupture, emboli, embolic stroke and other cerebral ischemic events, neurological deficits including stroke, ischemia, including death.(b)(4).The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-02323.

Event Description

On (b)(6) 2021, the patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, the physician placed one smart coil into the target location.While attempting to advance another smart coil within its introducer sheath, the smart coil would not advance at all from its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using additional smart coils.On (b)(6) 2021, the patient suffered several mini embolic subacute bihemispheric infarctions.The patient was started on 100 mg of acetylsalicylic acid daily.On (b)(6) 2021, information was received indicating that the event was resolved on (b)(6) 2021.On (b)(6) 2021, additional information was received indicating that on (b)(6) 2021 the patient was transferred to another hospital with slight psychomotor slowdown without focal neurologic signs and pain compensation.The several mini embolic subacute bihemispheric infarctions were reported to be a non-serious adverse event with a possible relationship to the smart coil and a probable relationship to the index procedure.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra clinical research associate on 10/08/2021: 1.Section d.Box 4.Catalog # is unknown; therefore, should be blank.2.Section d.Box 4.Unique identifier is unknown; therefore, should be blank.

• 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: 12652642
• MDR Text Key: 278558049
• Report Number: 3005168196-2021-02324
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014593
• UDI-Public: 00814548014593
• Combination Product (y/n): Y
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400SMTSTD0408
• Device Catalogue Number: 400SMTSTD0408
• 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: 10/08/2021
• 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: 53 YR
• Patient Sex: Female