Surpass Streamline M003SFD040200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252648734), received between Sep 10, 2019 and May 31, 2020 — classified as 4 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS PUBLISHED IN A LITERATURE ABSTRACT THAT CASES PERFORMED BETWEEN 10-JAN-2019 TO 02-JAN-2020 ON A TOTAL OF 55 PATIENTS WITH 68 TREATED ANEURYSMS WERE TREATED WITH FLOW DIVERTER (SUBJECT DEVICE). THERE WERE PROCEDURE RELATED COMPLICATIONS REPORTED IN 12 PATIENTS. ONE PATIENT WAS TREATED WITH IMPLANT OF A FLOW DIVERTER (SUBJECT DEVICE) FOR UNRUPTURED ANEURYSM 8 X 5 MM (ANEURYSM SIZE 5-9.9 MM) ON THE RIGHT POSTERIOR COMMUNICATING ARTERY RECURRENTLY STENTED WITH NON-STRYKER COILS AND NON-STRYKER STENT . THERE WAS MINOR COMPLICATION OF LEFT FACIAL DROOP AND LEFT WRIST WEAKNESS IMMEDIATELY POST PROCEDURE. THERE WAS NO DEFINITIVE STENT-ASSOCIATED THROMBUS CAUSING NEUROLOGICAL SYMPTOMS ON REPEAT ANGIOGRAPHY. THE PATIENT WAS TREATED WITH INTRAARTERIAL INTRACATHETER INTRACEREBRAL INTEGRILLIN 1 MG AND TISSUE PLASMINOGEN ACTIVATOR (TPA) 2 MG IN EVENT MICROEMBOLISM WOULD BE PRESENT. PERSISTENT FACIAL NUMBNESS FOLLOWING REPEAT ANGIOGRAM/THROMBOLYSIS. 1 MONTH LATER, PERSISTENT FILLING OF ANEURYSM MEASURING 12 X 7 MM ON AAGNETIC RESONANCE ANGIOGRAPHY (MRA).

  Patient problems: Neurological Deficit/Dysfunction; Thrombus

  MAUDE report 10103968 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SUCCESSFUL FLOW DIVERTER (SUBJECT DEVICE) PLACEMENT ON THE INTERNAL CAROTID ARTERY (ICA). AN INITIAL STENT WAS ATTEMPTED TO BE PLACED BUT IT DID NOT TRACK AS INTENDED. THE PHYSICIAN AND PROCTOR DECIDED ON A SECOND STENT (SUBJECT DEVICE) 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.

  Patient problems: Hemorrhage, Cerebral; Intracranial Hemorrhage

  MAUDE report 9142826 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL END OF THE SUBJECT STENT WAS FOUND DAMAGED AND THE PATIENT EXPERIENCED STOKE POST STENTING PROCEDURE. MEDICAL INTERVENTION WAS PERFORMED TO TREAT THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 09, 2019 INDICATING THAT THE PATIENT IS CURRENTLY EXPERIENCING FACIAL DROOP DUE TO THE STROKE.

  Patient problems: Facial Nerve Paralysis; Stroke/CVA

  MAUDE report 9089432 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH AND HALF POST STENTING OF A FLOW DIVERTER (SUBJECT DEVICE), THE PATIENT SUFFERED A STROKE WITH RIGHT-SIDED HEMIPARESIS AND DYSPHASIA THAT REQUIRING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. ACCORDING TO THE PHYSICIAN, THE REASON FOR THE STROKE WAS THAT THE PERFORATORS WERE COMING OUT OF THE ANEURYSM DOME IN THE MIDDLE CEREBRAL ARTERY M1 SEGMENT. IT IS UNDERSTOOD THAT THE SUBJECT DEVICE IMPLANTATION CONTRIBUTED TO THE BLOCKAGE OF THE PERFORATOR LEADING TO STROKE.

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA

  MAUDE report 8985752 ↗