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

Catalog Number	400SMTSTD0725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	09/21/2017
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.Thrombus formation 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery using penumbra smart coils (smart coils).During the procedure, there was a thrombus formation in the right middle cerebral artery which did not cause any neurological deficits.The patient was given medication and the event was resolved the same day (b)(6) 2017.The event was reported to be a non-serious adverse event with a definite relationship to the smart coil system and 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: 7806525
• Report Number: 3005168196-2018-01665
• Device Sequence Number: 1637705
• Product Code: HCG
• UDI-Device Identifier: 00814548014555
• UDI-Public: 00814548014555
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 07/27/2018
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 400SMTSTD0725
• 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: 07/27/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: 49 YR
• Date Report Sent to FDA: 01/01/2005