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 Problem Vascular Dissection (3160)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

The device history record review could not be performed since the lot number was not known.The subject device was not returned as it was implanted; therefore, functional testing as well as physical analysis could not be performed.The reported event is anticipated in nature as per the product directions for use.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of anticipated procedural complication will be assigned to this complaint.Subject device is not available.

Event Description

It was published in the journal of interventional neurology, an article stating that two iatrogenic cervical ica dissections occured in a study of the subject flow diverter, one of which was treated with further flow diversion from unknown manufacturer.The other ica dissection was missed at the time of the procedure and resulted in the occlusion of the vessel.No further information is available.

• 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 9470539
• MDR Text Key: 170791871
• Report Number: 3008881809-2019-00390
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other