MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

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

Patient Problem Vascular Dissection (3160)

Event Date 08/01/2015

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 in the labeling with the penumbra system include, but are not limited to, dissection, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, distal embolization, vessel spasm, thrombosis, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2021-00832, 3005168196-2021-00833.

Event Description

During its post-market surveillance activities on (b)(6) 2021, penumbra inc.Became aware of a journal article titled, "single-center experience using the 3max reperfusion catheter for the treatment of acute ischemic stroke with distal arterial occlusions" (premat et al.2017).This article reports a single center retrospective analysis of thirty-two mechanical thrombectomy cases using a penumbra system 3max reperfusion catheter (3maxc), occurring between august 2015 and december 2016.Of the thirty-two cases, it was reported that three 3maxc-related complications occurred and vasospasms were observed in seven cases after using the 3maxc to perform direct aspiration first pass (adapt).During one procedure, a 3max-related vascular rupture occurred at the m1-m2 genu and was subsequently managed by glue occlusion.In two other procedures, emboli in new territory (ent) were observed after use of the 3maxc; however, the ents were easily removed using the adapt technique and were not responsible for any clinical sequelae.It was also observed that vasospasm occurred in seven procedures after the 3maxc was used to perform adapt passes.However, in three cases the vasospasms spontaneously regressed before the end of the procedure.It was not possible to ascertain specific device or patient information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

• Brand Name: PENUMBRA SYSTEM 3MAX 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: 11710743
• MDR Text Key: 247728101
• Report Number: 3005168196-2021-00831
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/26/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/22/2021
• 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; Required Intervention