MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Model Number	PNML6F088804-R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01084.
Event or Problem Description
On (b)(6) 2021, the patient underwent a coil embolization procedure in the middle cerebral artery (mca)/ middle cerebral artery (mca) bifurcation using a neuron max 6f 088 long sheath (neuron max) and penumbra smart coils (smart coils).It was reported the patient had been previously treated for aneurysms.During the procedure, the neuron max was placed into the cervical right internal carotid artery (ica) using the roadmap technique, double flushed and connected to a continuous heparinized saline infusion.The patient had multiple vasospasms requiring 10mg ia in left vertebral artery and 5mg ia verapamil in right internal carotid artery (ica) and an additional 5mg.Balloon angioplasty was performed in m1 segment due to the vasospasms which were resolved on the same day.The vasospasm was reported to be a non-serious adverse event with a definite relationship to the index procedure and to the neuron max.During the procedure, the first smart coil was successfully implanted.While placing the second smart coil thrombus formation was noted.Half cardiac bolus dose of tirofiban was administered, and later another half cardiac dose of tirofiban was administered.Patient was given tirofiban iv drip overnight and was monitored.The ischemic stroke was resolved.The patient was discharged home in stable condition with no symptoms.The ischemic stroke was reported to be a serious adverse event with a definite relationship to the index procedure and possible relationship to the smart coil.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from a medical affairs associate indicated that the device was disposed of and is no longer available for return.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 neuron max system include, but are not limited to, vessel spasm, thrombosis, dissection, or perforation.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 number: 3005168196-2021-01084.H3 other text: placeholder.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11845804
• Report Number: 3005168196-2021-01083
• Device Sequence Number: 14367656
• Product Code: DQY
• UDI-Device Identifier: 00815948022379
• UDI-Public: 00815948022379
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021
• 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: 08/21/2023
• Device Model Number: PNML6F088804-R
• Device Catalogue Number: PNML6F088804
• Device Lot Number: H10706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005