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

Catalog Number 400SMTHXSFT1H3

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

Patient Problems Infarction, Cerebral (1771); Vitreous Floaters (1866); Weakness (2145)

Event Date 05/22/2017

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 events.From the complaint description, the physician suspected that the eye floaters may have been transient due to the larger amount of contrast administered during the procedure than normal.Allergic reaction and anaphylaxis from contrast media, embolic stroke and other cerebral ischemic events are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, the reported transient eye floaters and scattered punctuated infarct events are considered 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: 3005168196-2017-01001, 3005168196-2017-01002, 3005168196-2017-01003, 3005168196-2017-01004, 3005168196-2017-01005, 3005168196-2017-01006, 3005168196-2017-01007.The device was implanted into the patient.

Event Description

On (b)(6) 2017, the patient underwent a coil embolization procedure in the anterior communicating artery using eight penumbra smart coils (smart coils) with no complications.Later that day, the patient was found to have transient eye floaters in the left eye of moderate severity.A computed tomography (ct) was taken and was negative for stroke.The physician suspected that the eye floaters may have been transient due to the larger amount of contrast administered during the procedure than normal.No other action was taken to treat this event.On (b)(6) 2017, the patient experienced neurological decline of right-sided weakness, resulting in prolonged hospitalization.A ct angiography was taken, which showed scattered punctuated infarcts throughout the bilateral frontal and parietal lobes suggestive of embolic disease.No action was taken to treat this event.The patient was discharged the next day on (b)(6) 2017.The reported transient eye floaters was adjudicated by the physician to be possibly related to the disease state, procedure, and the smart coil system.The reported neurological decline was adjudicated by the physician to be unrelated to the disease state, possibly related to the smart coil system, and definitely related to the procedure.As of (b)(6) 2017, both of the transient eye floaters and scattered punctuated infarct events are still ongoing.

• Brand Name: PENUMBRA SMART COIL
• 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: 6665042
• MDR Text Key: 78347273
• Report Number: 3005168196-2017-01008
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015668
• UDI-Public: 00814548015668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 400SMTHXSFT1H3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• 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
• Patient Age: 67 YR