MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Perforation of Vessels (2135); No Information (3190)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

This is 4 of 8 reports.The device is not available to the manufacturer.

Event Description

It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device).There were procedure related complications reported in 12 patients and a confirmed guidewire perforation (unknown manufacturer) (distal mca(middle cerebral artery) vessel perforation) due to technical difficulty in device deployment (subject device) was reported.This report addresses the complications.No further information is available.

Event Description

It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device).There were procedure related complications reported in 12 patients and a confirmed guidewire perforation (unknown manufacturer) (distal mca(middle cerebral artery) vessel perforation) due to technical difficulty in device deployment (subject device) was reported.This report addresses the complications.No further information is available.Additional information received on 7-may-2020 and filed under mfr report # 3008881809-2020-00110: it was reported that the patient (2nd patient) was treated for a left superior hypophyseal artery, 4 mm, and left para ophthalmic artery, 3 mm aneurysm (aneurysm size <5 mm) with the flow diverter stent (subject device).There was technical difficulty in device deployment that resulted in left angular branch of left middle cerebral artery (mca) guidewire perforation.Cerebral infarct was observed.The patient was treated with onyx and nbc glue.There was suspected intermittent active extravasation given the continued growth of hematoma on ct head.Brain death was declared next day to procedure.

Manufacturer Narrative

Based on additional information received on 7-may2020, it was found that this initial report mfr report # 3008881809-2020-00108 related to the same event described in mfr report # 3008881809-2020-00110.Please refer to mfr report # 3008881809-2020-00110 for the continuation of the mdr filing process of the alleged issue associated with the subject complaint device.This is 4 of 14 reports (corrected).

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9968083
• MDR Text Key: 187952736
• Report Number: 3008881809-2020-00108
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (UNKNOWN MANUFACTURER); GUIDEWIRE (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Other