Intergard IGW0008-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00384401000037), received between Dec 14, 2017 and Nov 22, 2022 — classified as 4 injuries, 3 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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; Paresis

  MAUDE report 15848902 ↗
• 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 SEPTEMBER 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; Paresis

  MAUDE report 15834992 ↗
• MalfunctionJan 26, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  WITH (B)(4), THE CUSTOMER RECEIVED AN ARTICLE IN WHICH THE OUTER PACKAGING WAS SLIGHTLY DAMAGED. TO BE ON THE SAFE SIDE, THE ITEM IS RETURNED BACK AND THE CUSTOMER WILL RECEIVE NEW GOODS. IT IS CONSIGNMENT GOODS. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13357746 ↗
• MalfunctionDec 23, 2021Inaccurate Information; Inaccurate Information

  SEE MFG REPORT(S) # 1640201-2021-00042. COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13076698 ↗
• MalfunctionNov 27, 2020Flaked; Flaked

  COMPLAINT #: (B)(4). BEFORE THE IMPLANTATION OF THE GRAFT, THE USER RECOGNIZED DEPOSITS ON THE INNER LAYER OF THE GRAFT. THE PROBLEM WAS SEEN BEFORE THE USE, DIRECTLY AFTER OPENING THE PACKAGE, THEREFORE NO PATIENT WAS INVOLVED. THE SURGERY WAS NOT DELAYED. NO DETAILS WERE PROVIDED BY THE USER REGARDING THE ASPECT OF THE DEPOSITS FOUND ON THE INNER LAYER OF THE GRAFT. THE PRODUCT HAS BEEN RETURNED BY THE CUSTOMER FOR FURTHER INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 10914011 ↗
• InjuryFeb 8, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THE GRAFT WAS BLEEDING DURING SURGERY. HE MENTIONED SPOTS WHERE THERE WAS DISCRETE BLEEDING ALONG THE LENGTH OF THE GRAFT. IT REQUIRED THE APPLICATION OF SURGICAL SEALANT (COSEAL) TO TRY TO MINIMIZE BLOOD LOSS. A VIDEO IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 8321275 ↗
• InjuryDec 14, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN HEMIARCH REPLACEMENT SURGERY, IT WAS REPORTED THAT OOZING OCCURRED ON THE BODY OF THE GRAFT. THE OOZING ISSUE DID NOT REQUIRE ADDITIONAL TRANSFUSION, NOR PROLONGED SURGERY. IT WAS REPORTED THAT THE PATIENT WAS STABLE.

  Patient problems: Blood Loss

  MAUDE report 7116891 ↗