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

Catalog Number 400SMTXSFT0204

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

Patient Problems Ischemia (1942); Weakness (2145); Numbness (2415)

Event Date 09/26/2017

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.Potential adverse events with the penumbra smart coil (smart coil) system as noted in the device labeling include: ischemia and neurological deficits including stroke.Therefore, it was determined that the reported ischemic stroke was a potential complication related to the use of the smart coil.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2018-00735, 3005168196-2018-00736, 3005168196-2018-00738.The device was implanted into the patient.

Event Description

On (b)(6) 2017, the patient underwent a balloon assisted coil embolization procedure in the right internal carotid artery (ica) using penumbra smart coils (smart coils) with no reported complications.On (b)(6) 2017, the patient experienced an ischemic stroke and presented to the emergency room (er) with left upper extremity numbness and weakness.It was reported that the patient was on warfarin for stroke prevention with atrial fibrillation but held her therapy one week prior for three days, for a colonoscopy.Therefore, the patient received intravenous tissue plasminogen activator (iv tpa) and was admitted to the neurological intensive care unit (icu).The patient¿s medication was also switched to eliquis and aspirin and the stroke resolved.On (b)(6) 2017, the patient was discharged to inpatient rehab.The reported ischemic stroke was adjudicated to be an adverse event with a possible relationship to the penumbra smart coil system and 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: 7408210
• MDR Text Key: 104731052
• Report Number: 3005168196-2018-00737
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 00814548015286
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 400SMTXSFT0204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• 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; Required Intervention
• Patient Age: 75 YR