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

Catalog Number UNK_NEU

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

Patient Problems Intracranial Hemorrhage (1891); Visual Impairment (2138)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

This is the 11th of 14 reports.Subject device remains implanted.

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.One patient was treated with implanting of a flow diverter (subject device) for unruptured aneurysms on the right posterior communicating artery, 3.5 x 3 mm (aneurysm size < 5mm ).The patient suffered a minor complication of retinal hemorrhage on pod 7 and seizures on pod 7 with focus on opposite side of aneurysm.Outcome was improvement of vision.Remains on antiseizure medication.According to the physician, the minor complication was not related to the surpass stent.

Manufacturer Narrative

Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device dfu.As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.As per the surpass streamline dfu, intented use/indications for use: the surpass streamline flow diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width = 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter = 2.5 mm and = 5.3 mm.The available information indicates that the patient was treated with implanting of a flow diverter (subject device) for unruptured aneurysms on the right posterior communicating artery, 3.5 x 3 mm (aneurysm size < 5mm ).Based upon medical review assessment, the data reasonably suggest the clinical event is anticipated in nature and severity as per the dfu/risk documents.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

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.One patient was treated with implanting of a flow diverter (subject device) for unruptured aneurysms on the right posterior communicating artery, 3.5 x 3 mm (aneurysm size < 5mm ).The patient suffered a minor complication of retinal hemorrhage on pod 7 and seizures on pod 7 with focus on opposite side of aneurysm.Outcome was improvement of vision.Remains on antiseizure medication.According to the physician, the minor complication was not related to the surpass stent.

• 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: 10104100
• MDR Text Key: 193661548
• Report Number: 3008881809-2020-00165
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• 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: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR