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

Device Problem Migration (4003)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/20/2020

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 hematoma or hemorrhage at access site of entry, coil herniation into parent vessel, intercranial hemorrhage , vessel spasm, thrombosis, dissection, or perforation.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-00136.

Event Description

(b)(6) 2020, the patient underwent a coil embolization procedure in the anterior cerebral artery (aca) and anterior communicating artery (acom) using penumbra smart coils (smart coils), a non-penumbra microcatheter and glide catheter.During the procedure, the physician administered aspirin to the patient.The left internal carotid artery (ica) was selected using the glide catheter.The ica revealed a left aca a1 occlusion and left aca pericallosal artery coil migration.Due to the complex aneurysm and established left frontal intraventricular hemorrhage, the decision was made to avoid retrieving the migrated smart coil.This event is ongoing.The coil migration was reported to be a serious adverse event with a possible relationship to the smart coil and a definite relationship to the index procedure.The physician continued with the procedure.The fifth smart coil was noticed to be kinked upon removal from the hoop.The damage to the smart coil was found prior to use, and the smart coil was not used in the procedure.Subsequently, the physician experienced difficulty advancing next smart coil in the introducer sheath, and the smart coil was removed.The procedure was completed successfully as the physician accessed the daughter sac of the aneurysm and coiled it.It was reported the patient had an external ventricular drain (evd) removed and no spasm.

Event Description

The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) and anterior communicating artery (acom) using penumbra smart coils (smart coils), a non-penumbra microcatheter and glide catheter.During the procedure, a smart coil was noticed to be kinked upon removal from the hoop.The damage to the smart coil was found prior to use, and the smart coil was not used in the procedure.The physician then experienced difficulty advancing a new smart coil in the introducer sheath; therefore, the smart coil was removed from the patient.The physician placed four smart coils in the aneurysm lumen.It was noted that a coil migrated into the left aca.Due to the complex aneurysm and established left frontal intraventricular hemorrhage, the decision was made to avoid retrieving the migrated smart coil.This event is ongoing.The coil migration was reported to be a serious adverse event with a possible relationship to the smart coil and a definite relationship to the index procedure.

Manufacturer Narrative

Please note that the following section has been updated based on additional information provided by the penumbra clinical team on 01/14/2021: 1.Section b.Box 5.Describe event or problem.This report is associated with mfr report number: 3005168196-2021-00136, h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11206188
• MDR Text Key: 227946392
• Report Number: 3005168196-2021-00137
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR