Surpass Streamline M003SFD040300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252648796), received between Jun 20, 2019 and May 31, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 ON THE LEFT OPHTHALMIC ARTERY WITH COMPRESSION OF OPTIC CHIASM, 19 X 16 MM (ANEURYSM SIZE 5-20 MM) WITH VERY WIDE NECK, & B/L VERTEBRAL DYSPLASIA. SUCCESSFUL SURPASS ASSISTED COILING EMBOLIZATION OF LARGE LEFT OPHTHALMIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO ANGIOGRAPHIC COMPLICATIONS FROM THE PROCEDURE. HOWEVER, AFTER THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA, EXPRESSIVE APHASIA AND RIGHT HEMIPARESIS WERE NOTED. HEAD COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED WHICH SHOWED POSTOPERATIVE CHANGES BUT NO EVIDENCE OF HEMORRHAGE OR INFARCT. ANGIOGRAM REPEATED AND WAS NEGATIVE FOR DEFINITIVE CLOT, THE PATIENT WAS TREATED WITH INTRAARTERIAL INTRACATHETER INTRACEREBRAL TISSUE PLASMINOGEN ACTIVATOR (TPA) 2 MG AND INTEGRILLIN 2 MG IN LEFT INTERNAL CAROTID ARTERY (ICA) AND KEPT ON AN INTEGRILIN DR

  Patient problems: Stroke/CVA; Thrombosis

  MAUDE report 10103947 ↗
• InjuryMay 18, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT DEVICE (STENT) WAS DEPLOYED PREMATURELY IN THE WRONG LOCATION. THE SUBJECT DEVICE STENT WAS FULLY DEPLOYED FROM MIDDLE CEREBRAL ARTERY (MCA) TO CAVERNOUS INTERNAL CAROTID ARTERY (ICA) AND CONTROLLED BLEEDING TO AN EXTENT BUT LANDED FURTHER DISTAL THAN ANTICIPATED. THE PHYSICIAN TRIED TO DRAG THE SUBJECT STENT PROXIMAL INTO THE ICA AND THE PATIENT¿S BLOOD PRESSURE SPIKED UP WHICH CAUSED AN ANEURYSM RUPTURE NEAR DISTAL SEGMENT OF SUPRACLINOID ICA. THE SUBJECT DEVICE WAS UNABLE TO BE REMOVED ONCE FULLY DEPLOYED SO LEFT IN PLACE AND DECIDED NOT TO COIL. THE PATIENT WAS ADMINISTERED WITH THE MEDICATION IN RESPONSE TO THE ANEURYSM RUPTURE. PATIENT HAD AN EVD (EXTERNAL VENTRICULAR DRAIN) PLACED IMMEDIATELY AFTER THE PROCEDURE. PATIENT¿S CURRENT STATUS IS SICK BUT STABLE.

  Patient problems: Aneurysm; High Blood Pressure/ Hypertension; Rupture

  MAUDE report 10065501 ↗
• InjuryMay 5, 2020Component Missing; Component Missing

  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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10025679 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT STENT WAS SUCCESSFULLY IMPLANTED DURING THE PROCEDURE; HOWEVER, TWO DAYS POST PROCEDURE, THE PATIENT EXPERIENCED VISION CHANGES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 8719407 ↗