MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WS0300150

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was not available.

Event Description

It was reported the stent inner body broke inside the patient.There was no clinical consequence reported due to this event.

Event Description

It was reported the stent inner body broke inside the patient.There was no clinical consequence reported due to this event.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The reported event is covered in the device directions for use (dfu).The risk of the reported event has been addressed in the risk documentation and there are current controls in place to mitigate the risk of the as reported event.Based on the information currently available, it is probable the tortuosity of the patients anatomy may have caused difficulties during the procedure, therefore an assignable cause of procedural factors will be assigned to the investigation.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.0 X 15MM
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8893844
• MDR Text Key: 154310995
• Report Number: 3008881809-2019-00241
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 04546540722805
• UDI-Public: 04546540722805
• Combination Product (y/n): N
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003WS0300150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1