Intergard IGW0010-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401000051), received between Nov 21, 2022 and Dec 5, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED TO INTERVASCULAR FROM A FOREIGN AUTHORITY REPORT (NMPA) THAT BOTH ENDS OF THE GRAFT THREAD FRAYED, AND THE GRAFT WAS REPLACED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT, ACCORDING TO THE SALES TEAM INVESTIGATION, THIS ISSUE OCCURRED BECAUSE THE SURGEON "TOOK THE WRONG PRODUCT. THIS SURGERY SHOULD HAVE BEEN DONE WITH A DIFFERENT BRAND". THE MATERIAL AND THE USAGE OF THE OTHER BRAND'S GRAFT ARE DIFFERENT FROM INTERVASCULAR'S. THEREFORE, WHEN THEY CUT THE GRAFT, THERE WAS SOME LOOSENING AT BOTH ENDS OF THE GRAFT. THE SURGEON REALIZED THAT IT WASN¿T THE GRAFT THEY WANTED TO USE, AND THEN SWITCHED TO ANOTHER BRAND. THERE WAS NO HARM TO THE PATIENT, AND NO PICTURE OF THE GRAFT WAS PROVIDED. THE PRODUCT WON¿T BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855539 ↗
• InjuryNov 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED TO INTERVASCULAR THAT: "THE CLINIC REPORTED FOUR CASES OF ISCHEMIC STROKE (MULTIPLE EMBOLIZATION) TO THE DISTRIBUTOR OF OUR PRODUCTS AFTER A BRACHIOCEPHALIC ARTERY REPLACEMENT (SUBCLAVIAN ARTERY, LEFT INTERNAL CAROTID ARTERY AND BRACHIOCEPHALIC TRUNK) WITH INTERGARD PROSTHESES. THUS, ALL FOUR PATIENTS WERE USED ALL THREE TYPES OF PROSTHESES, 10 CM EACH: REF (B)(4). OPERATIONS WERE PERFORMED UNDER CARDIOPULMONARY BYPASS WITH HIGH HEPARINIZATION AND FLOW THROUGH THE PROSTHESIS. ALL PATIENTS ARE ALIVE AND ARE CURRENTLY IN ICU. THEY STARTED WORKING WITH INTERGARD PROSTHESES FROM THE END OF (B)(6) 2022. PREVIOUSLY, VASCUTEC PROSTHESES WERE USED FOR THIS TYPE OF PROSTHETICS (20 PATIENTS, WHILE USING READY-MADE MULTI-BRANCH PROSTHESES), THERE WERE NO COMPLICATIONS. STROKES WERE DIAGNOSED THE NEXT DAY AFTER SURGERY. ALL FOUR CASES IN OCTOBER (AGE, SEX, DATES OF OPERATIONS COULD NOT BE NAMED). OPERATING SURGEONS ARE DIFFERENT. AFTER A SERIES OF COMPLICATIONS, IT WAS DECIDED TO CONDUCT AN EXPERIMENT WITH AN IN-VITRO PROSTHESIS.THEY OPENED A NEW PACKAGE, SOAKED IN A SOLUTION OF RIFAMPICIN, SAW AN UNEVEN COATING OF COLLAGEN, WITH A MAXIMUM ACCUMULATION OF COLLAGEN IN

  Patient problems: Ischemia Stroke; Quadriplegia; Syncope/Fainting

  MAUDE report 15846811 ↗
• InjuryNov 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED TO INTERVASCULAR THAT: "THE CLINIC REPORTED FOUR CASES OF ISCHEMIC STROKE (MULTIPLE EMBOLIZATION) TO THE DISTRIBUTOR OF OUR PRODUCTS AFTER A BRACHIOCEPHALIC ARTERY REPLACEMENT (SUBCLAVIAN ARTERY, LEFT INTERNAL CAROTID ARTERY AND BRACHIOCEPHALIC TRUNK) WITH INTERGARD PROSTHESES. THUS, ALL FOUR PATIENTS WERE USED ALL THREE TYPES OF PROSTHESES, 10 CM EACH: REF IGW0012-30, REF IGW0010-30, IGW0008-30. OPERATIONS WERE PERFORMED UNDER CARDIOPULMONARY BYPASS WITH HIGH HEPARINIZATION AND FLOW THROUGH THE PROSTHESIS. ALL PATIENTS ARE ALIVE AND ARE CURRENTLY IN ICU. THEY STARTED WORKING WITH INTERGARD PROSTHESES FROM THE END OF ON (B)(6) 2022. PREVIOUSLY, VASCUTEC PROSTHESES WERE USED FOR THIS TYPE OF PROSTHETICS (20 PATIENTS, WHILE USING READY-MADE MULTI-BRANCH PROSTHESES), THERE WERE NO COMPLICATIONS. STROKES WERE DIAGNOSED THE NEXT DAY AFTER SURGERY. ALL FOUR CASES IN OCTOBER (AGE, SEX, DATES OF OPERATIONS COULD NOT BE NAMED). OPERATING SURGEONS ARE DIFFERENT. AFTER A SERIES OF COMPLICATIONS, IT WAS DECIDED TO CONDUCT AN EXPERIMENT WITH AN IN-VITRO PROSTHESIS. THEY OPENED A NEW PACKAGE, SOAKED IN A SOLUTION OF RIFAMPICIN, SAW AN UNEVEN COATING OF COLLAGEN, WITH A

  Patient problems: Ischemia Stroke; Quadriplegia; Syncope/Fainting

  MAUDE report 15835058 ↗