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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	02/14/2021
Type of Reportable Event	Serious Injury
Additional 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.Therefore, it was determined that the reported adverse event was an anticipated complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2021-02309, 3005168196-2021-02310, 3005168196-2021-02311, 3005168196-2021-02312, 3005168196-2021-02313, 3005168196-2021-02314, 3005168196-2021-02316.
Event or Problem Description
On (b)(6) 2021, the patient underwent a coil embolization procedure in the internal carotid artery (ica) and posterior communicating artery (pcom) using penumbra smart coils (smart coils) and a benchmark 6f 071 delivery catheter (benchmark) without any procedural complications or device malfunctions.On (b)(6) 2021, a computed tomography (ct) scan was taken and an ischemic stroke in the ipsilateral m4 segment of the middle cerebral artery (mca) was noted.Subsequently, the patient¿s blood pressure was monitored.The patient was also administered mild heparin and no progression of the stroke was observed.The patient was in stable condition, intubated and on analgesics.The event was considered resolved the same day with clinical sequelae.On (b)(6) 2021, information was received indicating that the ischemic stroke was unrelated to the smart coils and probably related to the index procedure.On (b)(6) 2021, additional information was received indicating that the ischemic stroke was possibly related to the smart coils.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the clinical investigator on 03-nov-2021: this report is associated with mfr report numbers: 3005168196-2021-02309; 3005168196-2021-02310; 3005168196-2021-02311; 3005168196-2021-02312; 3005168196-2021-02313; 3005168196-2021-02314; 3005168196-2021-02316.H3 other text: placeholder.
Event or Problem Description
Additional information received on 03-nov-2021 indicated that the ischemic stroke was adjudicated by the clinical investigator to be unrelated to the smart coils and related to the index procedure.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: 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: 12651408
• Report Number: 3005168196-2021-02315
• Device Sequence Number: 13813407
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2025
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F97341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005