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

Catalog Number 4002C0510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Weakness (2145); Lethargy (2560)

Event Date 06/15/2018

Event Type  Injury  

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: 3005168196-2018-01423, 3005168196-2018-01424, 3005168196-2018-01425, 3005168196-2018-01426.

Event 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 03-jul-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
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7707633
• MDR Text Key: 114622565
• Report Number: 3005168196-2018-01427
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010496
• UDI-Public: 00814548010496
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4002C0510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 79 YR