HydroCoil HelicalRecalls & reported problems across all models

We found 2 models of HydroCoil Helical by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2021 and Jun 15, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation Failure” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HydroCoil Helical recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 7, 2023Open, Classified

   Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

   Z-2238-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported HydroCoil Helical problems

HydroCoil Helical models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HydroCoil Helical 140205HES-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 recall2 reports
• HydroCoil Helical 140203HES-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent HydroCoil Helical adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A FRED EPI STUDY, ON (B)(6) 2021, A (B)(6) YEAR OLD FEMALE PATIENT RECEIVED EMBOLIZATION TREATMENT FOR A GIANT LEFT CAVERNOUS CAROTID ANEURYSM, PARTLY THROMBOSED, RESPONSIBLE FOR AN ORBITAL APEX SYNDROME WITH OCULOMOTOR DISORDERS AND DECREASED VISUAL ACUITY, IN ASSOCIATION WITH A COMPRESSIVE OPTIC NEUROPATHY. THE PATIENTS SYMPTOMS BEGUN APPROXIMATELY 18 MONTHS PRIOR TO THE INITIAL MANAGEMENT, WHICH WAS PERFORMED IN (B)(6) 2020 BY PARTIAL SEALING OF THE ANEURYSM SAC WITH MULTIPLE COILS FOLLOWED BY ADDITIONAL EMBOLIZATION ON (B)(6) 2021 BY DEPLOYMENT OF AN FDV FRED. PRE PROCEDURE NEUROLOGICAL EVALUATION WAS MRS SCORE 1. AT THE END OF THE TREATMENT, THE FDV FRED FULLY COVERS THE ANEURYSM NECK. THE POST PROCEDURAL ANGIOGRAPHIC RESULT IS A RESIDUAL SAC (RIII) AND THE PARENT ARTERY REMAINS WITHOUT STENOSIS. AFTER TREATMENT, THE PATIENT SHOWED IMPROVEMENT IN VISUAL ACUITY AND OCULOMOTOR DISTURBANCE. PATIENT DISCHARGED (B)(6) 2021. ON (B)(6) 2021 (38DAYS POST PROCEDURE COMPLICATION), THE PATIENT VISUAL ACUITY AND OCULOMOTOR DISTURBANCE WORSENED. ON (B)(6) 2021, PATIENT HAD A NEURO OPHTHALMOLOGY CONSULTATION WHICH REVEALED A WORSENING OF THE STRABISMUS FOR WHICH IT WAS A

  Patient problems: Aneurysm; Visual Impairment

  MAUDE report 12005447 ↗
• InjuryMay 20, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A FRED STENT TO TREAT AN ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY, THE PROXIMAL PART OF THE STENT MOVED DISTALLY AND WAS NO LONGER IN THE SAME POSITION. IT COULD NOT BE DETERMINED IF THE ANEURYSM NECK WAS STILL COVERED. A CLOT WAS OBSERVED IN THE SECOND HALF OF THE STENT AND NO CONTRAST WAS VISIBLE DISTAL TO THE STENT. THE PATIENT WAS TREATED WITH AGGRASTAT (TIROFIBAN) IN BOLUS IMMEDIATELY, THEN AN INFUSION AT 18 HOURS. THE VESSEL WAS OPENED COMPLETELY. THE PATIENT IS STILL RECOVERING, BUT IS WAS REPORTED TO BE IMPROVING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11853463 ↗
• InjuryApr 23, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT A FRED 4508 STENT WAS DEPLOYED TO TREAT AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE PATIENT WAS PRETREATED WITH A REGIMEN OF ASPIRIN AND CLOPIDOGREL STARTING FIVE DAYS PRIOR TO TREATMENT. AFTER DEPLOYMENT AND DETACHMENT, THE FRED4508 STENT FORESHORTENED DISTALLY AND THE ANEURYSM WAS NOT COMPLETELY COVERED. IT WAS DECIDED TO USE A SECOND FRED STENT TO COVER THE DISTAL PART OF THE ANEURYSM. DURING INSERTION OF THE MICROCATHETER, THE PATIENT SHOWED AN ICA OCCLUSION AND INTRAVENOUS INTEGRILIN WAS ADMINISTERED. AFTER A FEW MINUTES, ALL VESSELS WERE OPEN AND A REMODELING BALLOON WAS USED INSIDE OF THE FIRST FRED 4508 STENT. DURING THE INFLATION OF THE BALLOON, AN INCOMPLETE OPENING IN THE CURVE WAS VISIBLE. THE SECOND FRED STENT WAS THEN DEPLOYED. DYNA-CT AT THE END SHOWED NO VESSEL OCCLUSIONS.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11713674 ↗

Other Microvention, Inc. products

• Azur CX Detachable22 models · 509 reports · 1 recall
• Stent63 models · 237 reports · 2 recalls
• Azur Detachable Helical HydroCoil42 models · 190 reports
• V-Trak75 models · 147 reports
• WEB14 models · 134 reports
• AZUR14 models · 104 reports
• HydroSoft 3D26 models · 101 reports
• MicroPlex Helical Soft9 models · 8 reports · 1 recall