MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 30MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	M003SFD040300
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported during procedure, the resistance was encountered when introducing the subject device (streamline) into the body of catalyst catheter.The distal radiopaque marker (ro) came off of the subject device outer body catheter portion of the stent delivery system.Since the ro marker came off of the system, the stent was deployed in error where it was not intended to be placed.The physician decided to use different stent and coils to embolize the aneurysm.The ro marker was removed from the patient via mechanical aspiration.The procedure was completed with no clinical consequence to the patient.Post procedure, the physician reviewed the case in detail and thinks that the ro marker from the subject device catheter was either lodged within catalyst catheter or was floating around in the rhv (rotating hemostatic valve).Only until the physician did an injection through the catalyst catheter then see the ro marker shoot out of catalyst catheter and become lodged on the stent strut that was just deployed moments prior to the injection.
Event or Problem Description
It was reported during procedure, the resistance was encountered when introducing the subject device (streamline) into the body of catalyst catheter.The distal radiopaque marker (ro) came off of the subject device outer body catheter portion of the stent delivery system.Since the ro marker came off of the system, the stent was deployed in error where it was not intended to be placed.The physician decided to use different stent and coils to embolize the aneurysm.The ro marker was removed from the patient via mechanical aspiration.The procedure was completed with no clinical consequence to the patient.Post procedure, the physician reviewed the case in detail and thinks that the ro marker from the subject device catheter was either lodged within catalyst catheter or was floating around in the rhv (rotating hemostatic valve).Only until the physician did an injection through the catalyst catheter then see the ro marker shoot out of catalyst catheter and become lodged on the stent strut that was just deployed moments prior to the injection.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection revealed that the radio opaque (ro) marker was detached from the damaged distal tip of the delivery catheter and the stabilizer was kinked at 47cm and 74cm from the proximal end.The subject flow diverter stent was not returned.Following the functional test, the stabilizer was able to move freely within the delivery catheter.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, when the md introduced the streamline system into the cat5 he noted that he did catch the tip of the catheter in the hub, and then felt resistance when introducing into the body of cat5.Resistance was felt approximately 2-3 inches in from the hub.The device was returned, and it was confirmed that the ro marker had detached, also the stent stabilizer was kinked.It is probable that the device was damaged during insertion into and advancement through the proximal end of the cat5 catheter causing the ro marker to detach.An assignable cause of procedural factors will be assigned to the reported event and to the analysed ¿ ro marker(s) detached/separated/not visible under fluoroscopy¿ and ¿ stent stabilizer kinked/ bent¿, 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.

• Brand Name: SURPASS STREAMLINE 4.0MM X 30MM - PMA
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10025679
• Report Number: 3008881809-2020-00136
• Device Sequence Number: 2937290
• Product Code: OUT
• UDI-Device Identifier: 07613252648796
• UDI-Public: 07613252648796
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: M003SFD040300
• Device Catalogue Number: M003SFD040300
• Device Lot Number: 21686632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALYST 5 (STRYKER); SYNCHRO2 STANDARD (STRYKER); CATALYST 5 (STRYKER); SYNCHRO2 STANDARD (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR