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

Catalog Number	400SMTSFT0408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Weakness (2145); Numbness (2415)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional 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: 3005168196-2018-00736, 3005168196-2018-00737, 3005168196-2018-00738.The device was implanted into the patient.
Event or Problem 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7408240
• Report Number: 3005168196-2018-00735
• Device Sequence Number: 1233444
• Product Code: HCG
• UDI-Device Identifier: 00814548015088
• UDI-Public: 00814548015088
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: TO
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 400SMTSFT0408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR