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

Catalog Number 400SMTSFT0410

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

Patient Problems Ischemia (1942); Neurological Deficit/Dysfunction (1982); Weakness (2145)

Event Date 05/14/2018

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: 3005168196-2018-01174, 3005168196-2018-01175.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) on (b)(6) 2018 using penumbra smart coils (smart coils).During the procedure, the physician implanted non-penumbra coils and three smart coils.The patient then experienced left hemiparesis four hours after the embolization procedure.The patient was given an integrilin bolus to treat the stroke, and the patient¿s nihss score decreased from 12 to 0 with residual weakness of the left lower extremity, with dorsiflexion and plantar flexion 2/5.This event is considered resolved as of (b)(6) 2018.The stroke was adjudicated to be a serious adverse event with a possible relationship to the smart coil procedure, and a probable relationship to the procedure.

• 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: 7605681
• MDR Text Key: 111194527
• Report Number: 3005168196-2018-01173
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015095
• UDI-Public: 00814548015095
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 400SMTSFT0410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• 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): Life Threatening; Other; Required Intervention
• Patient Age: 60 YR