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

Catalog Number	4002C1040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Weakness (2145); Lethargy (2560)
Date of Event	06/15/2018
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.Ischemia and neurological deficits including stroke are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, it was determined that these reported adverse events were anticipated procedural complications.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2018-01424, 3005168196-2018-01425, 3005168196-2018-01426, 3005168196-2018-01427.
Event or Problem Description
On (b)(6) 2018, the patient underwent a coil embolization procedure to treat a rupture aneurysm using penumbra coils 400 (pc400s) with no issues.The next day, the patient health status declined.A computerized tomography/computerized tomography angiogram (ct/cta) then magnetic resonance imaging (mri) were ordered.The patient remains weak on right side and somnolent.According to the physician, the mri with left side infract that appeared more watershed.The cta was clear beyond the coil mass.The magnetic resonance angiography (mra) showed some narrowing near the coil mass which is partially artifact but overall looks patent.The patient is already on acetylsalicylic acid (asa) and had heparin during case.The patient was discharged to a rehabilitation center on (b)(6) 2018.As of (b)(6) 2018, the event was still considered unresolved.The left cerebral watershed stroke was reported to be a serious adverse event with a probable relationship to the pc400 system and the procedure.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7707481
• Report Number: 3005168196-2018-01423
• Device Sequence Number: 10945615
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 06/20/2018
• 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: 4002C1040
• 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: 06/20/2018
• Initial Report FDA Received Date: 07/20/2018
• 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: Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005