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

Catalog Number	400SMTHXSFT0204
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Thromboembolic events are included as possible complications in the instructions for use (ifu) for the penumbra smart coil system.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: 1.3005168196-2023-00441, 2.3005168196-2023-00442.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the m2 branch of the middle cerebral artery (mca) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the smart coil using a microcatheter into the target vessel and attempted to detach the smart coil using the handle; however, the smart coil failed to detach.The physician attempted to manually detach the smart coil; however, it would still not detach.Therefore, the physician decided to remove the smart coil.While retracting, the smart coil unintentionally detached within the microcatheter.The physician then used a microwave to advance the smart coil out of the microcatheter and into the target vessel.Next, the physician placed two smart coils in the target location successfully.The physician then advanced a fourth smart coil to the target vessel and attempted to detach the smart coil using the handle; however, the smart coil failed to detach.The physician attempted to manually detach the smart coil; however, it would not detach.While retracting the smart coil, the smart coil unintentionally detached within the microcatheter.The physician used the microwire to push the detached smart coil into the target location.It was reported that the same issue occurred with the fifth smart coil.After the coils were placed, the physician noticed a thrombus in the m3, m4 branch of the mca.A thrombectomy procedure was attempted; however, the non-penumbra catheter was unable to reach the thrombus.Therefore, the patient was treated with tpa.Later, bleeding was noticed at the site.The procedure was considered completed and the patient was transferred to the icu.The physician attributes the thrombus to the smart coils.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the m2 branch of the middle cerebral artery (mca) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the smart coil using a microcatheter into the target vessel and attempted to detach the smart coil using the handle; however, the smart coil failed to detach.The physician attempted to manually detach the smart coil; however, it would still not detach.Therefore, the physician decided to remove the smart coil.While retracting, the smart coil unintentionally detached within the microcatheter.The physician then used a microwire to advance the smart coil out of the microcatheter and into the target vessel.Next, the physician placed two smart coils in the target location successfully.The physician then advanced a fourth smart coil to the target vessel and attempted to detach the smart coil using the handle; however, the smart coil failed to detach.The physician attempted to manually detach the smart coil; however, it would not detach.While retracting the smart coil, the smart coil unintentionally detached within the microcatheter.The physician used the microwire to push the detached smart coil into the target location.It was reported that the same issue occurred with the fifth smart coil.After the coils were placed, the physician noticed a thrombus in the m3, m4 branch of the mca.A thrombectomy procedure was attempted; however, the non-penumbra catheter was unable to reach the thrombus.Therefore, the patient was treated with tissue plasminogen activator (tpa).Later, bleeding was noticed at the m3 due to the tpa.The procedure was considered completed and the patient was transferred to the icu.The physician attributes the thrombus to the smart coils.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 10/24/2023: 1.Section b.Box 5.Describe event or problem.This report is associated with mfr report numbers: 1.3005168196-2023-00441, 2.3005168196-2023-00442.H3 other text : placeholder.

• 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: 17844125
• Report Number: 3005168196-2023-00440
• Device Sequence Number: 7183070
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 814548015712
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F114116
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005