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

Model Number	M003UZAS30240
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hematoma (1884); No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10312362
• Report Number: 3008881809-2020-00216
• Device Sequence Number: 19555646
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 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
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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: Other; Required Intervention
• Patient Age: 37 YR