MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number M003UZAS30240

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that during a stent-assisted coiling of an aneurysm procedure, there was an hematoma at the puncture site with active bleeding that required treatment by protamine sulfate.The adverse event of hematoma was non-serious and resolved 2 days post-procedure without sequelae.According to the physician, the hematoma was related to the subject stent delivery system and to the procedure.

Event Description

It was reported that during a stent-assisted coiling of an aneurysm procedure, there was an hematoma at the puncture site with active bleeding that required treatment by protamine sulfate.The adverse event of hematoma was non-serious and resolved 2 days post-procedure without sequelae.According to the physician, the hematoma was related to the subject stent delivery system and to the procedure.

Manufacturer Narrative

Based on additional information received on 24-july-2020, it was noted that the data entry was wrongly entered.The correct information is that the hematoma was not related to the subject stent delivery system.Therefore, there is no complaint against the subject stent delivery system.The manufacturer has reviewed all information and determined this event no longer meets the requirement of a reportable event for the subject device.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10312362
• MDR Text Key: 200012711
• Report Number: 3008881809-2020-00216
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 19383071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR