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

Model Number	400SMTSFT0610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Thrombus (2101)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Thrombosis is included as a potential complication with the penumbra smart coil system and is a risk associated with the disease state and the procedure, and is included in the product labeling.Therefore, it was determined that the reported thrombus formation was an anticipated complication.Based on the information provided, there is no indication of a device malfunction that contributed to the reported event.This report is associated with mfr report numbers: 3005168196-2017-01375 3005168196-2017-01376.The device was implanted in the patient.
Event or Problem Description
On (b)(6) 2017, the patient underwent a coil embolization procedure in the left internal carotid terminus using penumbra smart coils (smart coils).After the procedure, a follow-up angiography was performed which revealed thrombus formation and subsequent occlusion; therefore, intra-arterial integrilin was administered to resolve the occlusion.The thrombus formation was adjudicated by the physician to have a definite relationship to the smart coil system.
Additional Manufacturer Narrative
Please note that the following statement in section h.Box 10./11.Narrative/corrected data was inadvertently missed in the initial mdr and is being updated on this follow-up #01 mfr report: 3005168196-2017-01374.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: 3005168196-2017-01375 and 3005168196-2017-01376.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG,KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6795527
• Report Number: 3005168196-2017-01374
• Device Sequence Number: 162566
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017
• 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: Physician
• Device Expiration Date: 09/21/2021
• Device Model Number: 400SMTSFT0610
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: F71736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 06/05/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005