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

Catalog Number 400SMTHXSFT1H04

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

Patient Problems Thrombosis (2100); Thrombus (2101)

Event Date 11/28/2017

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 event.A potential adverse event with the penumbra smart coil system include thrombosis and is noted in the labeling.Therefore, it was determined that the reported thrombus formation was a potential complication related to the use of the penumbra smart coil system.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2017-02282, 3005168196-2017-02283.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure in the left superior cerebellar artery using penumbra smart coils (smart coils).During the procedure, there was thrombus formation in the parent vessel.Therefore, the patient was given integrilin and the event resolved on the same day.The reported thrombus formation was adjudicated to have a definite relationship to the angiographic procedure and a possible relationship to the penumbra smart coil system.

• 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: 7146560
• MDR Text Key: 95777580
• Report Number: 3005168196-2017-02284
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015675
• UDI-Public: 00814548015675
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 400SMTHXSFT1H04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 55 YR