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

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

Patient Problems Cardiac Arrest (1762); Ruptured Aneurysm (4436)

Event Date 03/14/2022

Event Type  Death  

Manufacturer Narrative

The smart coil was implanted in the patient and 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.Aneurysm rupture is included as a possible complication in the instructions for use (ifu) for the penumbra 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 left middle cerebral artery (mca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician successfully implanted several smart coils in the target vessel using the microcatheter and the handle.Subsequently, the physician advanced the next smart coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the physician manually detached the smart coil by breaking the proximal end of the pusher assembly and pulling the inner pull wire.The procedure was completed using a new smart coil, the same handle, and the same microcatheter.There was no report of an adverse effect to the patient.On (b)(6) 2022 the patient was discharged.On (b)(6) 2022 the patient was admitted to the emergency room due to a subarachnoid hemorrhage (sah) and cardiac arrest.The patient had a glasgow coma scale (gcs) score of 3 with fixed and dilated pupils.Comfort measures only (cmo) was initiated.On (b)(6) 2022 the patient expired.The aneurysm rupture was reported to be a serious adverse event with a possible relationship to the smart system and a probable 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: 15477129
• MDR Text Key: 300549540
• Report Number: 3005168196-2022-00448
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/01/2005,09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: 08/31/2022
• 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): Death
• Patient Age: 78 YR
• Patient Sex: Female