MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C0306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	04/29/2012
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.A potential adverse event with the penumbra coil system include thrombosis and is included in the labeling.Therefore, it was determined that the reported thrombus formation was an anticipated complication.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: 3005168196-2016-01066, 3005168196-2016-01067, 3005168196-2016-01068, 3005168196-2016-01070, 3005168196-2016-01071, 3005168196-2016-01072, 3005168196-2016-01073.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery-posterior communicating artery (ica㐃om) using penumbra coil 400 coils (pc400 coils).During the procedure, after eight pc400 coils were deployed and detached in the aneurysm, minimal thrombus formation was noted at the aneurysm neck.Therefore, the patient was administered four thousand units of heparin and subsequently, the thrombus resolved.The reported minimal thrombus formation was adjudicated to have a definite relationship to the pc400 coil system, an unrelated relationship to the procedure and a possible relationship to the disease state.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5823741
• Report Number: 3005168196-2016-01069
• Device Sequence Number: 19000246
• Product Code: HCG
• UDI-Device Identifier: 00814548010441
• UDI-Public: 00814548010441
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2016

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: 11/30/2018
• Device Catalogue Number: 4002C0306
• Device Lot Number: F18795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2016
• Initial Report FDA Received Date: 07/26/2016
• 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: Other; Required Intervention
• Patient Age: 55 YR