IMPRA® ePTFE Vascular Grafts 40S06Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00801741021831), received between Feb 14, 2017 and Apr 13, 2022 — classified as 48 injuries, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (28 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT APPROXIMATELY 1600 DAYS POST STUDY CONDUIT PLACEMENT, PATIENT HAD AN ADVERSE EVENT OF THROMBOSIS OF VASCULAR ACCESS. IT WAS FURTHER REPORTED THAT, PATIENT UNDERWENT MECHANICAL THROMBECTOMY AND ANGIOPLASTY WITH STENT PLACEMENT PROCEDURE. THE EVENT WAS RESOLVED, AND THE PATIENT WAS DISCHARGED THE FOLLOWING THREE-DAYS POST PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14099852 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT POST CONDUIT IMPLANT INSERTED SURGICALLY, THE PATIENT HAD AN ADVERSE EVENT OF SEVERE BLEEDING, WHICH RESULTED IN HOSPITALIZATION. THE SUBJECT UNDERWENT LIGATION OF STUDY CONDUIT AND EXCISION OF PSEUDOANEURYSM. THE EVENT WAS DEFINITELY RELATED TO THE STUDY CONDUIT AND NOT RELATED TO THE STUDY PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13558040 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT POST CONDUIT IMPLANT INSERTED SURGICALLY, THE PATIENT WAS DIAGNOSED WITH INFECTION OF VASCULAR ACCESS WITH SEVERE INTENSITY, WHICH RESULTED IN HOSPITALIZATION. THE SUBJECT WAS TREATED WITH ANTIBIOTICS AND UNDERWENT SUBTOTAL EXCISION OF CONDUIT. THE EVENT WAS DEFINITELY RELATED TO THE STUDY CONDUIT AND NOT RELATED TO THE STUDY PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13051655 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT POST CONDUIT IMPLANT INSERTED SURGICALLY, THE PATIENT EXPERIENCED THE EVENTS OF HEMATOMA OUTSIDE THE ARTERIOVENOUS GRAFT (AVG), THROMBOSIS OF VASCULAR ACCESS WITH MODERATE INTENSITY AND STENOSIS OF VASCULAR ACCESS WITH MODERATE INTENSITY, WHICH RESULTED IN HOSPITALIZATION. THE SUBJECT UNDERWENT THROMBECTOMY AND ANGIOPLASTY AND THE EVENT OF THROMBOSIS OF VASCULAR ACCESS WAS CONSIDERED RESOLVED AND THE EVENT OF STENOSIS REMAINED UNRESOLVED. THE EVENTS WERE DEFINITELY RELATED TO THE STUDY CONDUIT AND NOT RELATED TO THE STUDY PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma; Stenosis; Thrombosis/Thrombus

  MAUDE report 12958340 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT THE SUBJECT EXPERIENCED MULTIPLE SERIOUS EVENTS OF THROMBOSIS AND STENOSIS OF VASCULAR ACCESS. APPROXIMATELY 1534 DAYS POST STUDY CONDUIT PLACEMENT, THE PATIENT WAS HOSPITALIZED DUE TO THROMBOSIS OF VASCULAR ACCESS AND ANEURYSM OF THE CONDUIT. APPROXIMATELY 1535 DAYS POST STUDY CONDUIT PLACEMENT, THE SUBJECT EXPERIENCED STENOSIS AND ANEURYSM OF VASCULAR ACCESS. THE SUBJECT UNDERWENT A THROMBECTOMY PROCEDURE, REMOVAL OF ANEURYSM AND SURGICAL REVISION. THE EVENT WAS RESOLVED ON THE SAME DAY AND THE SUBJECT WAS DISCHARGED THE FOLLOWING ONE-DAY POST PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 12680728 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE PATIENT ALLEGEDLY EXPERIENCED STENOSIS AND THROMBOSIS. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 12165615 ↗
• InjuryDec 16, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT APPROXIMATELY 1225 DAYS POST STUDY CONDUIT PLACEMENT, THERE WAS THROMBOSIS OF VASCULAR ACCESS. APPROXIMATELY 1261 DAYS POST STUDY CONDUIT PLACEMENT, THE PATIENT WAS HOSPITALIZED DUE TO THROMBOSIS OF VASCULAR ACCESS. APPROXIMATELY 1262 DAYS POST STUDY CONDUIT PLACEMENT, THE SUBJECT UNDERWENT A THROMBECTOMY AND THE EVENT WAS CONSIDERED RESOLVED. THE SAME DAY, THE PATIENT EXPERIENCED A SECOND THROMBOSIS OF VASCULAR ACCESS WHICH PROLONGED HOSPITALIZATION. APPROXIMATELY 1265 DAYS POST STUDY CONDUIT PLACEMENT, THE PATIENT UNDERWENT A REPEAT THROMBECTOMY WITH ANGIOPLASTY. THE THROMBOSIS WAS RESOLVED THE SAME DAY AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY POST UNEVENTFUL DIALYSIS. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11018518 ↗
• InjuryDec 8, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 1420 DAYS POST STUDY CONDUIT IMPLANT, THE SUBJECT EXPERIENCED THROMBOSIS OF THE VASCULAR ACCESS. A THROMBECTOMY PROCEDURE WAS PERFORMED AND THE EVENT WAS CONSIDERED RESOLVED. THE CURRENT STATUS OF THE SUBJECT WAS NOT PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10964543 ↗
• InjuryJul 1, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY THREE YEARS AND 28 DAYS POST PLACEMENT OF A LEFT UPPER ARM VASCULAR GRAFT, THE PATIENT EXPERIENCED THROMBOSIS AND STENOSIS OF VASCULAR ACCESS AND WAS ADMITTED TO THE HOSPITAL. THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY.

  Patient problems: Stenosis; Thrombosis

  MAUDE report 10220969 ↗
• InjuryJun 2, 2020Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY 908 DAYS POST IMPLANTATION, THE PATIENT EXPERIENCED INFECTION OF VASCULAR ACCESS. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS. THE PATIENT WAS DISCHARGED ONE DAY POST ADMITTANCE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY 1092 DAYS POST IMPLANTATION, THE PATIENT EXPERIENCED PSEUDO-ANEURYSM OF VASCULAR ACCESS. THE PATIENT WAS HOSPITALIZED AND DISCHARGED ONE DAY POST ADMITTANCE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis; Thrombosis; Unspecified Infection

  MAUDE report 10113098 ↗
• InjuryMay 21, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY 1058 DAYS AFTER CONDUIT PLACEMENT IN THE LEFT UPPER ARM, THE PATIENT EXPERIENCED STENOSIS OF VASCULAR ACCESS. IT WAS FURTHER REPORTED THAT AT THE 42 MONTH STUDY VISIT, THE PATIENT EXPERIENCED PROLONGED BLEEDING DURING DIALYSIS, AND AN ULTRASOUND SHOWED AN AREA OF STENOSIS. REPORTEDLY, APPROXIMATELY 17 DAYS LATER, THE PATIENT UNDERWENT A LEFT UPPER EXTREMITY LOOPAGRAM AND ANGIOPLASTY OF THE BRACHIAL ARTERY AND THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY. THE PATIENT WAS DISCHARGED ONE DAY POST ADMISSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 10081072 ↗
• InjuryApr 14, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY TWO YEARS AND TEN MONTHS POST PLACEMENT OF A LEFT UPPER ARM VASCULAR GRAFT, THE PATIENT EXPERIENCED THROMBOSIS AND STENOSIS OF VASCULAR ACCESS AND WAS ADMITTED TO THE HOSPITAL. THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. NEW INFORMATION: APPROXIMATELY 1052 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED BLEEDING OF VASCULAR ACCESS AND WAS HOSPITALIZED. THE SAME DAY, SURGERY WAS PERFORMED TO TREAT THE BLEEDING. IF WAS FURTHER REPORTED THAT 1055 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT A THROMBECTOMY FOR THROMBOSIS OF THE VASCULAR ACCESS. POST-PROCEDURE PHLEBOGRAPHY REVEALED STENOSIS OF THE VENOUS ANASTOMOSIS AND AXILLARY VEIN. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO TREAT THE STENOSIS. THE EVENT OF THROMBOSIS WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY.

  Patient problems: Injury; Stenosis; Thrombosis

  MAUDE report 9959285 ↗
• InjuryMar 18, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ELEVEN MONTHS POST PLACEMENT OF A LEFT UPPER ARM VASCULAR GRAFT, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THROMBOSIS OF VASCULAR ACCESS. THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE FOR SURGICAL REVISION OF VENOUS ANASTOMOSIS, AND ENDOPHLEBECTOMY OF THE AXILLARY VEIN. REPORTEDLY, AN ENDOPHLEBECTOMY WAS PERFORMED AND THE PATENCY OF THE PROXIMAL PORTION OF THE AXILLARY VEIN WAS RESTORED. GOOD RETROGRADE BLOOD FLOW WAS ACHIEVED. PATIENT DISCHARGED ON HOSPITAL DAY TWO.

  Patient problems: Thrombosis

  MAUDE report 9848579 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY 807 DAYS AFTER THE CONDUIT WAS SURGICALLY INSERTED, THE SUBJECT EXPERIENCED THROMBOSIS OF VASCULAR ACCESS WHICH REQUIRED HOSPITALIZATION AND ADDITIONAL MEDICAL INTERVENTION. THE PATIENT WAS DISCHARGED 11 DAYS POST ADMISSION DAY.

  Patient problems: Thrombosis

  MAUDE report 9591865 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY 735 DAYS POST IMPLANTATION, PATIENT EXPERIENCED INFECTION AS THE PATIENT WAS HOSPITALIZED AND DISCHARGED ONE DAY POST HOSPITALIZATION WITH ONGOING RESULT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED 756 DAYS POST INDEX PROCEDURE AND THE SUBJECT DEVELOPED SEPSIS AND UNDERWENT FOOT INCISION AND REMOVAL OF STUDY ACCESS. THE PATIENT WAS DISCHARGED 54 DAYS POST ADMISSION DAY.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9445986 ↗
• InjuryFeb 5, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT ONE YEAR TWO MONTHS POST STUDY CONDUIT PLACEMENT IN THE LEFT UPPER ARM THE PATIENT EXPERIENCED THROMBOSIS OF VASCULAR ACCESS. THROMBECTOMY WAS PERFORMED AND THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY.

  Patient problems: Thrombosis

  MAUDE report 8308779 ↗
• InjuryJan 23, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY 847 DAYS POST STUDY CONDUIT PLACEMENT IN THE LEFT FOREARM THE PATIENT EXPERIENCED STENOSIS OF VASCULAR ACCESS AND WAS HOSPITALIZED. SURGERY TO AUGMENT OUTFLOW WAS PERFORMED AND THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY. THE PATIENT WAS DISCHARGED ONE DAY POST ADMISSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 8272403 ↗
• InjuryNov 16, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE YEAR FOUR MONTHS POST STUDY CONDUIT PLACEMENT IN THE LEFT UPPER ARM, THE PATIENT REPORTEDLY EXPERIENCED THROMBOSIS OF VASCULAR ACCESS. THE PATIENT WAS ADMITTED FOR SURGICAL REVISION AND THROMBECTOMY OF THE STUDY CONDUIT AND LEFT UPPER EXTREMITY VESSELS. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY.

  Patient problems: Thrombosis

  MAUDE report 8081941 ↗
• InjuryOct 16, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE YEAR FIVE MONTHS POST VASCULAR GRAFT PLACEMENT IN THE UPPER ARM, THE SUBJECT EXPERIENCED THROMBOSIS OF VASCULAR ACCESS AND WAS ADMITTED TO THE HOSPITAL. THROMBECTOMY WAS PERFORMED AND FOLLOW-UP IMAGING DEMONSTRATED HIGH-GRADE STENOSIS WITH RESIDUAL THROMBUS AT THE VENOUS ANASTOMOSIS. ANGIOPLASTY WAS PERFORMED AT THE VENOUS ANASTOMOSIS AND VENOUS OUTFLOW TRACT. FOLLOWING THIS, AN EMBOLECTOMY CATHETER WAS USED TO REMOVE A PLATELET PLUG WITHIN THE ARTERIAL ANASTOMOSIS. REPEAT IMAGING DEMONSTRATED RESIDUAL CLOT AND REPEAT THROMBECTOMY AND ANGIOPLASTY WERE PERFORMED. THE FOLLOWING DAY, IMAGING DEMONSTRATED THE STUDY CONDUIT THROMBOSED. THROMBECTOMY WAS PERFORMED AND A TUNNELED CATHETER WAS PLACED FOR TEMPORARY ACCESS. THE SUBJECT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION.

  Patient problems: Stenosis; Thrombosis; Thrombosis/Thrombus

  MAUDE report 7972372 ↗
• InjuryOct 8, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE YEAR SIX MONTHS POST VASCULAR GRAFT PLACEMENT IN THE UPPER ARM, THE SUBJECT EXPERIENCED STENOSIS WITHIN THE GRAFT ANASTOMOSIS AND WAS ADMITTED TO THE HOSPITAL. REPORTEDLY, ANGIOPLASTY WAS PERFORMED AND FOLLOW-UP IMAGING DEMONSTRATED NO STENOSIS WITHIN THE GRAFT ANASTOMOSIS. THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE YEAR POST VASCULAR GRAFT PLACEMENT, THE SUBJECT EXPERIENCED STENOSIS OF VASCULAR ACCESS. APPROXIMATELY ONE YEAR SIX MONTHS POST VASCULAR GRAFT PLACEMENT, THE SUBJECT EXPERIENCED STENOSIS OF VASCULAR ACCESS.

  Patient problems: Stenosis

  MAUDE report 7943266 ↗
• InjuryOct 3, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE YEAR AND THREE MONTHS POST PLACEMENT OF AN UPPER ARM VASCULAR GRAFT, THE PATIENT EXPERIENCED THROMBOSIS OF VASCULAR ACCESS THAT WAS CONSIDERED TO BE LIFE THREATENING AND ADMITTED TO THE HOSPITAL. THE OUTCOME OF THE EVENT AND THE PATIENT STATUS IS UNKNOWN AT THIS TIME.

  Patient problems: Thrombosis

  MAUDE report 7931728 ↗
• InjurySep 13, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE YEAR AND FOUR MONTHS POST PLACEMENT OF AN UPPER ARM VASCULAR GRAFT, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THROMBOSIS OF VASCULAR ACCESS. REPORTEDLY, THE PATIENT UNDERWENT A THROMBECTOMY, FLOW IMPROVEMENT WAS ACHIEVED AND THE PATIENT DISCHARGED THE FOLLOWING DAY.

  Patient problems: Thrombosis

  MAUDE report 7875256 ↗
• InjuryAug 28, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE YEAR AND FIVE MONTHS POST PLACEMENT OF A LEFT UPPER ARM VASCULAR GRAFT, THE PATIENT EXPERIENCED THROMBOSIS OF VASCULAR ACCESS AND WAS HOSPITALIZED. REPORTEDLY, A THROMBECTOMY WAS PERFORMED; THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT DISCHARGED ON HOSPITAL DAY TWO.

  Patient problems: Thrombosis

  MAUDE report 7825340 ↗
• InjuryJul 26, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE YEAR AND THREE MONTHS POST PLACEMENT OF A RIGHT UPPER ARM VASCULAR GRAFT, THE PATIENT EXPERIENCED THROMBOSIS OF VASCULAR ACCESS AND WAS HOSPITALIZED. REPORTEDLY, ANGIOPLASTY, THROMBECTOMY AND STENT PLACEMENT WAS PERFORMED; THE PATIENT DISCHARGED ON HOSPITAL DAY SIX.

  Patient problems: Stenosis; Thrombosis

  MAUDE report 7723579 ↗
• InjuryJul 23, 2018Material Puncture/Hole; Obstruction of Flow; Material Puncture/Hole; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY TEN MONTHS POST PLACEMENT OF A LEFT UPPER ARM VASCULAR GRAFT, THE PATIENT WAS HOSPITALIZED AND SURGICAL RECONSTRUCTION AND THROMBECTOMY OF THE GRAFT WAS PERFORMED. IT WAS FURTHER REPORTED THAT A HEMATOMA, A HOLE IN THE GRAFT AND A PARTIALLY CLOTTED GRAFT WAS IDENTIFIED. REPORTEDLY, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT DISCHARGED ON HOSPITAL DAY EIGHT.

  Patient problems: Hematoma; Thrombus; Unspecified Infection

  MAUDE report 7712883 ↗