MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE); INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that the subject flow diverter was placed at the desired location by using a micro catheter.During deployment of the subject flow diverter, the physician mentioned that the distal tip did not open even after 50% of the device was unsheathed.The physician stopped the deployment and resheathed the subject flow diverter back into the micro catheter.The physician tried to deploy the subject flow diverter three times but the distal tip did not open.The subject device was withdrawn.No clinical consequences were reported to the patient due to this event and no further information is available.

Manufacturer Narrative

The neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # (b)(4).Guidance for industry and food and drug administration staff, (b)(6) 2016.Subject device is not available.

Event Description

It was reported that the subject flow diverter was placed at the desired location by using a micro catheter.During deployment of the subject flow diverter, the physician mentioned that the distal tip did not open even after 50% of the device was unsheathed.The physician stopped the deployment and desheathed the subject flow diverter back into the micro catheter.The physician tried to deploy the subject flow diverter three times but the distal tip did not open.The subject device was withdrawn.No clinical consequences were reported to the patient due to this event and no further information is available.

Event Description

It was reported that the subject flow diverter was placed at the desired location by using a micro catheter.During deployment of the subject flow diverter, the physician mentioned that the distal tip did not open even after 50% of the device was unsheathed.The physician stopped the deployment and resheathed the subject flow diverter back into the micro catheter.The physician tried to deploy the subject flow diverter three times but the distal tip did not open.The subject device was withdrawn.No clinical consequences were reported to the patient due to this event and no further information is available.

Manufacturer Narrative

H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.The device was received.The reported lot number was confirmed from the returned packaging.During visual inspection, the flow diverter was returned in its deployed state.There was damage noted to the proximal and distal ends of the flow diverter.There were no anomalies noted to the introducer sheath or the stent delivery wire.A functional test could not be performed as the flow diverter had been deployed.The reported complaint was confirmed based on device analysis.The device failed to meet when received for complaint investigation based on the analyzed anomalies noted to the device.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event 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 available information, the patient¿s anatomy was moderately tortuous.The device was returned for analysis and the flow diverter stent was noted to be deformed, which is indicative of the reported event.It is probable that the device may have been damaged due to the tortuosity of the patient¿s anatomy causing the reported event.An assignable cause of procedural factors will be assigned to the reported and analyzed events, 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.

Manufacturer Narrative

B1: adverse event/product problem: not applicable h1: type of reportable event: not applicable due to the automated mes 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.As per the available information, the ptients anatomy was moderately tortuous.The device was returned for analysis and the flow diverter stent was noted to be deformed, which is indicative of the reported event.It is probable that the device may have been damaged due to the tortuousity of the patients anatomy causing the reported event.An assignable cause of procedural factors will be assigned to the reported and the analysed events, as the issue is associated with a product that meets 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.Non-reportable rationale: based on further review, the reported event description, the subject flow diverter failed to open but was recaptured by the operator and successfully removed from the patient¿s body.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.

Event Description

It was reported that the subject flow diverter was placed at the desired location by using a micro catheter.During deployment of the subject flow diverter, the physician mentioned that the distal tip did not open even after 50% of the device was unsheathed.The physician stopped the deployment and resheathed the subject flow diverter back into the micro catheter.The physician tried to deploy the subject flow diverter three times but the distal tip did not open.The subject device was withdrawn.No clinical consequences were reported to the patient due to this event and no further information is available.

• Brand Name: UNKNOWN (SURPASS STREAMLINE)
• 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: 9293806
• MDR Text Key: 166794691
• Report Number: 3008881809-2019-00340
• 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,Followup,Followup
• Report Date: 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR XT 27 MICRO CATHETER (STRYKER)