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); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage, Cerebral (1889); No Consequences Or Impact To Patient (2199)

Event Date 09/15/2019

Event Type  Injury  

Manufacturer Narrative

This is the second of 2 reports.Subject device is not available.

Event Description

It was reported that an initial flow diverter stent (subject device) was attempted to be placed but it did not track as intended.The physician and proctor decided on a second stent which tracked and deployed without issue.Four days post-procedure, the patient was re-admitted to the hospital for a reperfusion hemorrhage.It has not been determined if the hemorrhage was caused by the surpass or if it was caused by pharmaceutical means.No additional information is available at this time.

Event Description

It was reported that an initial flow diverter stent (subject device) was attempted to be placed but it did not track as intended.The physician and proctor decided on a second stent which tracked and deployed without issue.Four days post-procedure, the patient was re-admitted to the hospital for a reperfusion hemorrhage.It has not been determined if the hemorrhage was caused by the surpass or if it was caused by pharmaceutical means.No additional information is available at this time.

Manufacturer Narrative

Based on stryker safety review on 4-oct-2019, the surgery was completed successfully, the subject stent was removed from the patient and there was no impact to the vessel.Therefore there is no relationship of the non-implanted subject stent to the hemorrhage.The manufacturer has reviewed all information and determined this event no longer meets the requirementt of the reportable event for the device in question.Product history review could not be performed as the lot number is unknown.However, due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.The reported device difficulty engaging target vessel issue is covered in the device directions for use (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.As per the additional information, the patients anatomy was tortuous.It is probable that the tortuous nature of the patients anatomy caused the reported difficulty engaging target vessel.An assignable cause of procedural factors will be assigned to this investigation as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.Device evaluated by mfg: corrected to no.

• 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
• MDR Report Key: 9142825
• MDR Text Key: 160841882
• Report Number: 3008881809-2019-00296
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR