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

Catalog Number 400SMTHXSFT0410

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

Patient Problems Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 10/13/2021

Event Type  Death  

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, hematoma or hemorrhage at access site of entry, intracranial hemorrhage, aneurysm rupture, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-02563.

Event Description

The patient was undergoing a stent-assisted coiling embolization procedure in the right anterior communicating artery (aca) using penumbra smart coils (smart coils), and a non-penumbra microcatheter.During the procedure, a smart coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using five additional smart coils and the same microcatheter.It was also reported that a periprocedural aneurysm rupture occurred, resulting in bleeding and causing patient expiration.However, the cause of the aneurysm rupture is unknown.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 11/18/2021: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Patient code 2.This report is associated with mfr report number: 3005168196-2021-02563 h3 other text : placeholder.

Event Description

The patient was undergoing a stent-assisted coiling embolization procedure in the right anterior communicating artery (aca) using penumbra smart coils (smart coils), and a non-penumbra microcatheter.During deployment of the second smart coil, an aneurysm rupture and a subarachnoid hemorrhage (sah) occurred.Subsequently, a balloon catheter was introduced to stop the bleeding.The coiling microcatheter was removed and a stenting microcatheter was introduced from the left internal carotid artery (ica) in the aca a2 segment.An aneurysm bridging stent was deployed into the left a1 segment without complications.While attempting to advance another smart coil, the coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.A total of five smart coils and the same microcatheter were used to successfully complete the procedure.There were no reported technical complications during use of the smart coils.It was reported that the patient expired due to the aneurysm rupture and subsequent sah.However, the relationship between the sah and use of the smart coil is unknown.

Event Description

The patient was undergoing a stent-assisted coiling embolization procedure in the right anterior communicating artery (aca) using penumbra smart coils (smart coils), and a non-penumbra microcatheter.During deployment of the second smart coil, an aneurysm rupture and a subarachnoid hemorrhage (sah) occurred.Subsequently, a balloon catheter was introduced to stop the bleeding.The coiling microcatheter was removed and a stenting microcatheter was introduced from the left internal carotid artery (ica) in the aca a2 segment.An aneurysm bridging stent was deployed into the left a1 segment without complications.While attempting to advance another smart coil, the coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.A total of five smart coils and the same microcatheter were used to successfully complete the procedure.There were no reported technical complications during use of the smart coils.It was reported that the patient expired two days post-procedure due to the aneurysm rupture and subsequent sah.However, the relationship between the sah and use of the smart coil is unknown.

Manufacturer Narrative

Please note that the following section is being updated based on additional information provided by the sales representative on 1/24/2022: 1.Section b.Box 5.Describe event or problem.Please note that the following sections were inadvertently missed on the follow-up #01 mfr report and are being included on this follow-up #02 mfr report: 3005168196-2021-02593.1.Section d.Box 4.Lot #, catalog #, expiration date, unique identifier.2.Section h.Box 4.Device manufacture date.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2021-02593.1.Section b.Box 2.Date of death.

• 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: 12833319
• MDR Text Key: 280927252
• Report Number: 3005168196-2021-02593
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400SMTHXSFT0410
• Device Lot Number: F103669
• 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: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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: 46 YR
• Patient Sex: Female