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

Model Number 400SMTSFT0820

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2018-00479, 3005168196-2018-00481.The hospital disposed of the device.

Event 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 patients 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.

Manufacturer Narrative

Correction to device manufacture date: to 10/4/2016.

Event 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.

Manufacturer Narrative

This report is associated with mfr report numbers: 3005168196-2018-00479 and 3005168196-2018-00481.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7324657
• MDR Text Key: 102080437
• Report Number: 3005168196-2018-00480
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• 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,Followup
• Report Date: 01/01/2005,02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/03/2021
• Device Model Number: 400SMTSFT0820
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F71895
• 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 Age: 65 YR