MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 40MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003113FPP0

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

Patient Problems Stroke/CVA (1770); Feeding Problem (1850); Loss of consciousness (2418); Insufficient Information (4580)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

This is 1 of 6 reports (1st mdr).

Event Description

It was reported during the procedure the stent (subject device) couldn't deploy.Post-procedure magnetic resonance imaging (mri) showed extensive infection.The patient¿s level of consciousness (jcs) was 1-3.The physician did not know the causal relationship with subject surpass or another device(s).Gooseneck snare was used as a medical intervention.The procedure was completed successfully.

Manufacturer Narrative

B5 executive summary ¿ updated.F10/h6 clinical signs code grid ¿ updated.D9 returned to manufacturer on ¿updated.

Event Description

It was reported during the procedure the stent (subject device) couldn't deploy.Post-procedure magnetic resonance imaging (mri) showed extensive infection (ischemic stroke).The patient¿s level of consciousness ( jcs) was 1-3 and unable to eat.The physician did not know the causal relationship with subject surpass or another device(s).Gooseneck snare was used as a medical intervention.The procedure was completed successfully.

Manufacturer Narrative

Section d.Suspect medical device - catalog # search - updated.Section d.Suspect medical device - gim search results - updated.Section d.Suspect medical device - gtin - check spelling - device identifier (di) number - updated.D1 product long description ¿ updated.

Event Description

It was reported during the procedure the stent (subject device) couldn't deploy.Post-procedure magnetic resonance imaging (mri) showed extensive infection (ischemic stroke).The patient¿s level of consciousness ( jcs) was 1-3 and unable to eat.The physician did not know the causal relationship with subject surpass or another device(s).Gooseneck snare was used as a medical intervention.The procedure was completed successfully.

Manufacturer Narrative

H4: manufacturing date: added.H3: device evaluated by mfg updated.H3: summary attached: updated.D4: expiration date: added.Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the returned stent was found to be deployed and not returned, the stent stabilizer was found to be kinked/bent, the stent delivery catheter was found to be kinked/bent, and the stent delivery catheter was found to be deformed.A functional test for the reported ¿stent failed/unable to deploy¿ was unable to perform as the stent was found to be deployed and not returned.While the reported complaint was not confirmed, the findings are consistent with the reported event.The device failed to meet specification when returned for device analysis.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 device was returned and it was found that the stent was deployed from the device on return, the stent stabilizer was kinked/bent, the stent delivery catheter was kinked/bent and also the stent delivery catheter was deformed.It is probable that the anatomical or procedural factors present during the clinical procedure contributed to the reported event.An assignable cause of procedural factors will be assigned to the reported ¿stent failed/unable to deploy¿, ¿patient stroke¿, ¿patient complication¿ and ¿patient abnormal image finding¿ and to the analyzed ¿stent deployed prematurely during use¿, ¿stent stabilizer kinked/bent¿, ¿stent delivery catheter kinked/bent¿, and ¿stent delivery catheter deformed¿, 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.

Event Description

It was reported during the procedure the stent (subject device) couldn't deploy.Post-procedure magnetic resonance imaging (mri) showed extensive infection (ischemic stroke).The patient¿s level of consciousness ( jcs) was 1-3 and unable to eat.The physician did not know the causal relationship with subject surpass or another device(s).Gooseneck snare was used as a medical intervention.The procedure was completed successfully.

• Brand Name: SURPASS STREAMLINE 4.0MM X 40MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13645356
• MDR Text Key: 286463207
• Report Number: 3008881809-2022-00091
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Catalogue Number: M003113FPP0
• Device Lot Number: 22510456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• 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
• Treatment: CAROTID WALLSTENT (NO-STRYKER MANUFACTURER).; CAT5 (STRYKER MANUFACTURER).; CHIKAI GW (NO-STRYKER MANUFACTURER).; GATEWAY BALLOON (STRYKER MANUFACTURER).; GUIDING SHEATH (NO-STRYKER MANUFACTURER).; OFFSET CATHETER (STRYKER MANUFACTURER).; TWO SURPASS STREAM LINE (STRYKER MANUFACTURER).
• Patient Outcome(s): Other; Required Intervention