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

Catalog Number	400SMTSFT0610
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Malposition of Device (2616)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported complaint indicated that the patient experienced a large stroke.Per the "potential adverse events" listed in the instructions for use, neurological deficits including stroke are possible complications related to embolization procedures using the penumbra smart coil system.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.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, the physician deployed an initial smart coil into the target vessel using a non-penumbra microcatheter.After detaching the smart coil, the physician noticed that a very stiff tail was present inside the microcatheter.The physician then attempted to push it out of the microcatheter with the second smart coil thinking that it was just the tail; however, upon pushing the tail of the smart coil out of the microcatheter with the second coil, the initial smart coil shot back into the parent vessel.The physician did not make any attempts to remove the initial coil since it was already detached.Consequently, the patient ended up having a large stroke due to the smart coil that was left in the parent vessel.It is unknown if the physician did anything to treat the stroke.As of (b)(6) 2017, the patient is still in the hospital.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6572786
• Report Number: 3005168196-2017-00748
• Device Sequence Number: 16330413
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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: 08/30/2021
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: F71409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/17/2017
• 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: Hospitalization; Life Threatening