MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

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

Patient Problem Embolus (1830)

Event Date 02/05/2017

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 events.Distal embolization event is a known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, the reported distal embolization events are considered 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 number: 3005168196-2017-01634.The hospital discarded the device.

Event Description

The patient underwent a thrombectomy procedure on (b)(6) 2017 in the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and a penumbra system 3max reperfusion catheter (3maxc).After the thrombus was aspirated using the ace68 and the 3maxc, a peripheral thrombus was seen at the bifurcation of the m2 segment.There was persistent flow around this distal thrombus, therefore, it was decided to not pursue further intervention to remove the thrombus.A 24-hour follow-up computed tomography (ct) scan did not reveal any change in the infarction area; therefore, the patient was discharged home on (b)(6) 2017 with a national institutes of health stroke scale (nihss) score of 0.The investigator reported that the event was a non-serious adverse event unrelated to the ace68 and 3maxc, and definitely related to the angiographic procedure.On (b)(6) 2017, this non-serious adverse event was adjudicated to be possibly related to the ace68, 3maxc, angiographic procedure, and index stroke.The outcome was considered to be resolved the same day, (b)(6) 2017.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: NRY
• 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: 6891847
• MDR Text Key: 87292957
• Report Number: 3005168196-2017-01633
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2017
• 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): Other
• Patient Age: 76 YR