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

Model Number	400SMTSTD1260
Medical Device Problem Codes	Material Deformation (2976); Migration (4003); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a ruptured aneurysm in the internal carotid artery (ica) using a penumbra smart coil (smart coil), non-penumbra coils and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target vessel using the microcatheter; however, the physician was not satisfied with the placement of the smart coil.While retracting the smart coil to reposition it, the smart coil seemed to have knotted on itself.Therefore, the physician decided to remove the smart coil and microcatheter together, but the smart coil unintentionally detached and migrated distally during the retraction process.The physician attempted to remove the detached smart coil using a snare device but was unsuccessful.A strand of the smart coil remained in the anterior cerebral artery (aca) and ica.The procedure was completed using additional coils to secure the aneurysm.There was no report of an adverse effect to the patient related to the smart coil migration.It was reported that the patient expired after the procedure because of complications caused by the subarachnoid hemorrhage.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10557453
• Report Number: 3005168196-2020-01535
• Device Sequence Number: 2842859
• Product Code: HCG
• UDI-Device Identifier: 00814548014449
• UDI-Public: 00814548014449
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2020
• 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: Health Professional
• Device Expiration Date: 05/17/2022
• Device Model Number: 400SMTSTD1260
• Device Catalogue Number: 400SMTSTD1260
• Device Lot Number: F77194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/18/2020
• 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: Required Intervention
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005