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

Model Number	400SMTSTD1160
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Codes	Death (1802); No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2018-00480; 3005168196-2018-00481.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil through a non-penumbra microcatheter, and the smart coil became stuck approximately 20 cm from the tip of the microcatheter; therefore, the smart coil was removed.The physician then attempted to advance a new smart coil using the same microcatheter, however the same incident occurred.The physician therefore removed the smart coil, and used the microcatheter to place another embolization system.The microcatheter was then removed, and a new non-penumbra microcatheter was placed.The physician then successfully deployed and detached two smart coils using the microcatheter.Next, while advancing a new smart coil through the microcatheter, the physician experienced resistance and was unable to advance the smart coil more than about halfway out of the tip of the microcatheter.The physician then attempted to advance the smart coil by applying more force, and consequently the smart coil pusher assembly broke outside of the patient near the rhv.The physician therefore removed the pusher assembly and found that the smart coil had unintentionally detached while partially inside the microcatheter.The physician removed the microcatheter, however the detached smart coil remained inside the patient with half of it hanging out of the target vessel and into the right subclavian artery.The physician attempted to remove the smart coil using a snare device, however was unsuccessful.The smart coil was therefore left in that position and the embolization procedure ended.The physician then began a thrombectomy procedure to treat a thrombus in the m1 of the middle cerebral artery (mca) using a velocity delivery catheter (velocity).The physician advanced the velocity through a penumbra system ace 68 reperfusion catheter (ace68) and a neuron max 6f 088 long sheath (neuron max).However, the physician was unable to advance the velocity to the target location due to the patient¿s anatomy being tortuous.The devices were therefore removed and the procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Lot number f75696; catalog number: 400smtstd1160; expiration date: 4/169/2022; udi number: (b)(4).Manufacture date: 4/17/2017.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil through a non-penumbra microcatheter, and the smart coil became stuck approximately 20 cm from the tip of the microcatheter; therefore, the smart coil was removed.The physician then attempted to advance a new smart coil using the same microcatheter, however, the same incident occurred.The physician, therefore, removed the smart coil and used the microcatheter to place another embolization system.The microcatheter was then removed, and a new non-penumbra microcatheter was placed.The physician then successfully deployed and detached two smart coils using the microcatheter.Next, while advancing a new smart coil through the microcatheter, the physician experienced resistance and was unable to advance the smart coil more than about halfway out of the tip of the microcatheter.The physician then attempted to advance the smart coil by applying more force, and consequently, the smart coil pusher assembly broke outside of the patient near the rhv.The physician, therefore, removed the pusher assembly and found that the smart coil had unintentionally detached while partially inside the microcatheter.The physician removed the microcatheter, however, the detached smart coil remained inside the patient with half of it hanging out of the target vessel and into the right subclavian artery.The physician attempted to remove the smart coil using a snare device, however, was unsuccessful.The smart coil was therefore left in that position and the embolization procedure ended.The physician then began a thrombectomy procedure to treat a thrombus in the m1 of the middle cerebral artery (mca) using a velocity delivery catheter (velocity).The physician advanced the velocity through a penumbra system ace 68 reperfusion catheter (ace68) and a neuron max 6f 088 long sheath (neuron max).However, the physician was unable to advance the velocity to the target location due to the patient¿s anatomy being tortuous.The devices were therefore removed and the procedure ended at this point.There was no report of an adverse effect to the patient.Post-procedure, the patient experienced left side weakness and deteriorating mental status.In an examination on (b)(6) 2018, the patient was markedly worse and stopped opening eyes to stimulation.A computed tomography (ct) scan of the patient's head revealed a large right middle cerebral artery (mca) territory infarct, significantly worsening right cerebral hemisphere mass effect and edema with a leftward midline shift of 15mm (previously 9mm), and subfalcine and uncal herniation.There was near complete effacement of the right lateral, third, and fourth ventricles.The patient was transferred home with hospice care on (b)(6) 2018 and passed away on (b)(6) 2018.The large right mca infarct and the worsening of the right cerebral hemisphere mass effect and edema was adjudicated to be an adverse event with a definite relationship to the smart coil and is unrelated to the procedure.
Additional Manufacturer Narrative
(b)(4).This report is associated with mfr report numbers: 3005168196-2018-00480 and 3005168196-2018-00481.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7324654
• Report Number: 3005168196-2018-00479
• Device Sequence Number: 10789068
• Product Code: HCG
• UDI-Device Identifier: 00814548014425
• UDI-Public: 00814548014425
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2018
• 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: Physician
• Device Expiration Date: 04/16/2022
• Device Model Number: 400SMTSTD1160
• Device Catalogue Number: 400SMTSTD1160
• Device Lot Number: F75696
• 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: 02/07/2018
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 10/03/2018; 02/26/2020
• 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: Death; Required Intervention
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005