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

Catalog Number 400SMTXSFT0408

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

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Paresis (1998)

Event Date 11/02/2017

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, non-conformance, or misuse that contributed to the reported event.Potential adverse events with the penumbra smart coil (smart coil) system include cerebral ischemic events and neurological deficits including cerebrovascular accident (cva) and are included in the labeling.Therefore, it was determined that the reported cerebrovascular accident was a potential complication related to the use of the 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: 1.3005168196-2017-02099, 2.3005168196-2017-02100, 3.3005168196-2017-02102, 4.3005168196-2017-02103.The device was implanted in the patient.

Event Description

The patient underwent a coil embolization procedure on (b)(6) 2017 using five penumbra smart coils.Within two hours after the procedure, the patient experienced acute neurologic decline and became hemiparetic.The patient underwent an endovascular revascularization therapy (ert) with a successful thrombolysis for acute stroke therapy and recanalization of the right middle cerebral artery (mca), achieving tici grade 3 flow.This event was resolved on (b)(6) 2017.The cerebrovascular accident (cva) was adjudicated to be a serious adverse event with a definite relationship to the disease state, a definite relationship to the procedure, and a probable relationship to the 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: 7068216
• MDR Text Key: 93244550
• Report Number: 3005168196-2017-02101
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 400SMTXSFT0408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• 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: 49 YR