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

Catalog Number	400SMTXSFT0202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Thrombosis is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported thrombus formation was an anticipated procedural complication.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2018-01219.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right anterior cerebral artery (aca) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed two smart coils in the target vessel using a non-penumbra microcatheter.Completion of the right carotid cerebral angiogram initially demonstrated a small amount of thrombus located at the distal neck of the azygos pericallosal aneurysm within the azygos pericallosal artery; however, at the conclusion of the procedure, the thrombus was resolved.There was no remedial therapy, medical procedure or hospitalization required to address the thrombus formation.The event was considered resolved the same day, (b)(6) 2018.The thrombus formation was reported to have a definite relationship to the smart coil system and unrelated to the procedure.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7622727
• Report Number: 3005168196-2018-01218
• Device Sequence Number: 19188058
• Product Code: HCG
• UDI-Device Identifier: 00814548015262
• UDI-Public: 00814548015262
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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: Physician
• Device Catalogue Number: 400SMTXSFT0202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/20/2018
• 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: Life Threatening
• Patient Age: 71 YR