Zilver Vena G57448Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10827002574486), received between May 11, 2021 and Mar 11, 2025 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21571787 ↗
• InjuryFeb 11, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  PER REP - THE DELIVERY WAS FINE. ONCE THE STENT WAS DEPLOYED, IT DID NOT EXPAND FULLY, EVEN AFTER POST-DILATION. THEY HAD TO PUT IN A COMPETITIVE VENOUS STENT INSIDE THE COOK STENT TO KEEP IT FULLY EXPANDED. PREFIX ZVT7: 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO: PER REP. 3.92 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO: YES. IF YES, PLEASE SPECIFY: MAY THURNER. 3.93 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER: OTHER. IF OTHER, PLEASE SPECIFY: COMPRESSED BECAUSE OF MAY THURNER. 3.94 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? N/A, YES, NO: NO. 3.95 WAS THE DEVICE USED PERCUTANEOUSLY? N/A, YES, NO: YES. 3.96 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? LEFT COMMON FEMORAL. 3.97 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER. FEMORAL IF OTHER, PLEASE SPECIFY: 3.98 WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? MAY THURNER. IF OTHER, PLEASE SPECIFY. 3.99 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355222 ↗
• InjuryJan 24, 2025Device Endoleak; Device Endoleak

  ACCORDING TO THE INITIAL REPORTER, THE DELIVERY WAS FINE. ONCE THE STENT WAS DEPLOYED, IT DID NOT EXPAND FULLY, EVEN AFTER POST-DILATION. THEY HAD TO PUT IN A COMPETITIVE VENOUS STENT INSIDE THE COOK STENT TO KEEP IT FULLY EXPANDED.

  Patient problems: Clinical Endoleak

  MAUDE report 21228457 ↗
• InjuryAug 22, 2024Migration; Migration

  THE PRACTICE WAS NOTIFIED OF A STENT MIGRATION INVOLVING A COOK ZILVER VENA STENT (REF ZVT7-35-80-16-100, G57448, LOT C1769829) WHICH WAS PLACED BY DR (B)(6) ON (B)(6) 2021. SURVEILLANCE ULTRASOUNDS IN OUR OFFICE LAST IDENTIFIED THE STENT VISUALIZED IN THE COMMON ILIAC ARTERY (TARGET VESSEL) ON 8DEC2022. THE PATIENT FAILED TO FOLLOW UP WITH OUR PRACTICE AFTER THAT DATE. THE STENT WAS INCIDENTALLY FOUND IN THE HEART ON OR AROUND 7JUN2024 DURING A FEVER WORKUP THE PATIENT UNDERWENT AT HARTFORD HEALTHCARE. REMOVAL WAS ATTEMPTED ENDOVASCULARLY BUT ULTIMATELY ACHIEVED THROUGH OPEN THORACOTOMY DUE TO ADHERENCE TO THE TRICUSPID VALVE, AND NECESSITATING A TRICUSPID VALVE REPLACEMENT. TO OUR BEST KNOWLEDGE, THE PATIENT IS ALIVE AT THIS TIME. -ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? -DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? - IF YES, PLEASE SPECIFY: -PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (IE WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER - IF OTHER, PLEASE SPECIFY: -WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? -WAS THE DEVICE USED PERCUTANEOUSLY? -WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? -WAS THE

  Patient problems: Fever

  MAUDE report 20041322 ↗
• InjuryAug 22, 2024Migration; Migration

  THE PRACTICE WAS NOTIFIED OF A STENT MIGRATION INVOLVING A COOK ZILVER VENA STENT (REF ZVT7-35-80-16-100, G57448, LOT C1769829) WHICH WAS PLACED BY DR (B)(6) ON (B)(6) 2021. SURVEILLANCE ULTRASOUNDS IN OUR OFFICE LAST IDENTIFIED THE STENT VISUALIZED IN THE COMMON ILIAC ARTERY (TARGET VESSEL) ON (B)(6) 2022. THE PATIENT FAILED TO FOLLOW UP WITH OUR PRACTICE AFTER THAT DATE. THE STENT WAS INCIDENTALLY FOUND IN THE HEART ON OR AROUND (B)(6) 2024 DURING A FEVER WORKUP THE PATIENT UNDERWENT AT HARTFORD HEALTHCARE. REMOVAL WAS ATTEMPTED ENDOVASCULARLY BUT ULTIMATELY ACHIEVED THROUGH OPEN THORACOTOMY DUE TO ADHERENCE TO THE TRICUSPID VALVE, AND NECESSITATING A TRICUSPID VALVE REPLACEMENT. TO OUR BEST KNOWLEDGE, THE PATIENT IS ALIVE AT THIS TIME. **PLEASE PROVIDE THE ORIGINATOR A LIST OF ANY ADDITIONAL MANUFACTURER QUESTIONS REQUIRED FOR INVESTIGATION. (B)(4) 24JUL2024. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? IF YES, PLEASE SPECIFY: PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (IE WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER IF OTHER, PLEASE SPECIFY: WAS A STENT PREVIOUSLY PLACED DURIN

  Patient problems: Fever

  MAUDE report 20034341 ↗
• InjuryAug 30, 2022Migration; Migration

  PER PATIENT'S WIFE HE HAD TO HAVE OPEN HEART SURGERY AT (B)(6) HOSPITAL (C21635-0) BECAUSE THE STENT HAD MIGRATED. HE HAD PROBLEMS WITH LEG SWELLING BEFORE THE STENT WAS IMPLANTED. HE HAD HIGH BLOOD PRESSURE AFTER THE IMPLANT AND THE LEG SWELLING BECAME WORSE DUE TO 60 MG OF LASIX. THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT THE VASCULAR EXPERTS (C43414-0). THE DOCTOR THOUGHT THE PATIENT HAD A MASS BUT IT WAS THE MIGRATED STENT. THE STENT HAD WRAPPED AROUND A VENTRICLE CAUSING A MINUTE LEAK. AFTER EXPLANT, IT WAS NOTICED THAT THE FILTER NEVER FULLY OPENED. NOW, THE PATIENT WAS NOT FEELING WELL/TIRED AND HAS HAD ANXIETY AFTER THE EXPLANT. AFTER CARDIAC PHYSICAL THERAPY, THEY PUT THE MACHINE ON HIM AND HE WENT INTO AFIB. HE IS NOT RECOVERING AS EXPECTED. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NOT THAT WAS REPORTED IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? YES. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES. IF YES, PLEASE DESCRIBE. -OPEN HEART SURGERY. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. IF YES, PLEASE

  Patient problems: High Blood Pressure/ Hypertension; Obstruction/Occlusion; Stacking Breaths

  MAUDE report 15321425 ↗
• InjuryAug 30, 2022Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  PER PATIENT'S WIFE - HE HAD TO HAVE OPEN HEART SURGERY AT (B)(6) BECAUSE THE STENT HAD MIGRATED. HE HAD PROBLEMS WITH LEG SWELLING BEFORE THE STENT WAS IMPLANTED. HE HAD HIGH BLOOD PRESSURE AFTER THE IMPLANT AND THE LEG SWELLING BECAME WORSE DUE TO 60 MG OF LASIX. THE DEVICE WAS IMPLANTED BY (B)(6). THE DOCTOR THOUGHT THE PATIENT HAD A MASS BUT IT WAS THE MIGRATED STENT. THE STENT HAD WRAPPED AROUND A VENTRICLE CAUSING A MINUTE LEAK. AFTER EXPLANT, IT WAS NOTICED THAT THE FILTER NEVER FULLY OPENED. NOW, THE PATIENT WAS NOT FEELING WELL/TIRED AND HAS HAD ANXIETY AFTER THE EXPLANT. AFTER CARDIAC PHYSICAL THERAPY, THEY PUT THE MACHINE ON HIM AND HE WENT INTO AFIB. HE IS NOT RECOVERING AS EXPECTED. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NOT THAT WAS REPORTED. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? YES. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES. IF YES, PLEASE DESCRIBE. OPEN HEART SURGERY. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. OPEN H

  Patient problems: Foreign Body Embolism; High Blood Pressure/ Hypertension; Obstruction/Occlusion; Stacking Breaths

  MAUDE report 15320015 ↗
• InjuryJul 1, 2022No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A FEMALE PATIENT IN HER 60S WITH COMPRESSION OF THE COMMON ILIAC AND EXTERNAL ILIAC VEINS ON RIGHT SIDE UNDERWENT AN IVUS AND VENOGRAPHY PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449 AND G57448, WERE USED. ACCESS SITE WAS RIGHT GROIN IVUS AND VENOGRAPHY WAS PERFORMED PHYSICIAN SELECTED 16X140 VENA TO STENT FROM THE CONFLUENCE INTO THE EXTERNAL ILIAC VEIN ON RIGHT SIDE. NO PREDILATION WAS DONE. AFTER DEPLOYING STENT OPTIMALLY, PHYSICIAN ADVANCED A BARD ATLAS 16X60 BALLOON INTO THE STENT. THE TECH WHO WAS SCRUBBED IN STATES THE PHYSICIAN WAS NOT STEPPING ON FLUORO WHILE ADVANCING BALLOON, AND ONCE HE DID STEP ON FLUORO BOTH THE PHYSICIAN AND TECH SAW THAT THE STENT HAD ALMOST COMPLETELY, ABOUT 95%, MIGRATED INTO THE PATIENT¿S IVC (PR365969). THEY BOTH AGREED THAT THE BALLOON CATHETER BUMPED THE CAUDAL EDGE OF THE STENT AND CAUSED IT TO MIGRATE SIGNIFICANTLY. PHYSICIAN ATTEMPTED TO USE THE BARD ATLAS BALLOON TO PULL THE STENT BACK DOWN INTO THE COMMON ILIAC, BUT WAS UNSUCCESSFUL. THEN, PHYSICIAN DEPLOYED ANOTHER 16X140 VENA INTO COMMON ILIAC, OVERLAPPING THE 2 STENTS A FEW CENTIMETERS. DUE TO STENT MIGRATION, A THIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883536 ↗
• InjuryJun 29, 2022Migration; Migration

  ACCORDING TO THE INITIAL REPORTER: A FEMALE PATIENT IN HER 60S WITH COMPRESSION OF THE COMMON ILIAC AND EXTERNAL ILIAC VEINS ON RIGHT SIDE UNDERWENT AN IVUS AND VENOGRAPHY PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449 AND G57448, WERE USED. ACCESS SITE WAS RIGHT GROIN AND A IVUS AND VENOGRAPHY WAS PERFORMED. THE PHYSICIAN SELECTED 16X140 VENA TO STENT FROM THE CONFLUENCE INTO THE EXTERNAL ILIAC VEIN ON RIGHT SIDE. NO PREDILATION WAS DONE. AFTER DEPLOYING STENT OPTIMALLY, PHYSICIAN ADVANCED A (ANOTHER MANUFACTURER'S) 16X60 BALLOON INTO THE STENT. THE TECH WHO WAS SCRUBBED IN STATES THE PHYSICIAN WAS NOT STEPPING ON FLUORO WHILE ADVANCING BALLOON, AND ONCE HE DID STEP ON FLUORO BOTH THE PHYSICIAN AND TECH SAW THAT THE STENT HAD ALMOST COMPLETELY, ABOUT 95%, MIGRATED INTO THE PATIENT¿S IVC (REF: (B)(4)). THEY BOTH AGREED THAT THE BALLOON CATHETER BUMPED THE CAUDAL EDGE OF THE STENT AND CAUSED IT TO MIGRATE SIGNIFICANTLY. PHYSICIAN ATTEMPTED TO USE THE BARD ATLAS BALLOON TO PULL THE STENT BACK DOWN INTO THE COMMON ILIAC, BUT WAS UNSUCCESSFUL. THEN, PHYSICIAN DEPLOYED ANOTHER 16X140 VENA INTO COMMON ILIAC, OVERLAPPING THE 2 STENTS A FEW CENTIMETERS. DUE TO STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854612 ↗
• InjuryJan 17, 2022Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER DEPLOYMENT (AND DILATION WITH A BALLOON) THE DEVICE MIGRATED FROM THE ILIAC INTO THE IVC." THE PHYSICIAN HAD TO MAKE AN ADDITIONAL ACCESS SITE TO USE A BALLOON TO THE PULL STENT MORE INTO THE IVC. PLACED ANOTHER BALLOON (COMPETITIVE COMPANY) DISTAL TO THE STENT TO OVERLAP-TO HOLD IT IN PLACE. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PATIENT/EVENT INFO - NOTES: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO? YES. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO? YES. IF YES, PLEASE SPECIFY: ASKU. PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? ASKU WAS TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266312 ↗
• InjuryJan 14, 2022Migration; Migration

  ACCORDING TO THE INITIAL REPORTER: "AFTER DEPLOYMENT (AND DILATION WITH A BALLOON) THE DEVICE MIGRATED FROM THE ILIAC INTO THE IVC." THE PHYSICIAN HAD TO MAKE AN ADDITIONAL ACCESS SITE TO USE A BALLOON TO THE PULL STENT MORE INTO THE IVC. PLACED ANOTHER BALLOON (ANOTHER MANUFACTURER) DISTAL TO THE STENT TO OVERLAP-TO HOLD IT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260566 ↗
• MalfunctionJan 7, 2022Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAIL: A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A FILTER PLACEMENT PROCEDURE IN WHICH A VENA CAVA 16X100 FILTER WAS USED. ACCESS WAS VIA RIGHT COMMON FEMORAL VEIN ANTEGRADE WITH COOK MEDICAL MPIS. STENT PLACEMENT WAS RIGHT COMMON ILIAC VEIN. IT WAS A 16X100, BUT WHEN DEPLOYED LOOKED MORE LIKE A 16X80. AFTER REVIEWING THE CASE, IT LOOKED LIKE THE STENT DEPLOYMENT SYSTEM WAS POSSIBLY PUSHED FORWARD DURING DEPLOYMENT CAUSING THE STENT STRUTS TO COLLAPSE TOGETHER. THE STENT WAS CHECKED WITH IVUS AND THE STENT DID NOT LOOK FRACTURED AND HAD LUMINAL GAIN. THE STENT COLLAPSE WAS NOTICED IMMEDIATELY POST DEPLOYMENT. ANGIOGRAPHIC FINDINGS: LEFT LOWER EXTREMITY - SYNECHIAE AND SPURS FORMATION LEFT COMMON ILIAC VEIN - SIGNIFICANT COMPRESSION, NARROWING AND STENOSIS WITH SIGNIFICANT VISIBLE REFLUX LEFT EXTERNAL ILIAC VEIN - SIGNIFICANT COMPRESSION, NARROWING AND REFLUX LEFT COMMON FEMORAL VEIN - MODERATE NARROWING RIGHT COMMON ILIAC VEIN - SIGNIFICANT COMPRESSION, NARROWING WITH REFLUX RIGHT EXTERNAL ILIAC VEIN - SIGNIFICANT COMPRESSION, NARROWING AND REFLUX RIGHT COMMON FEMORAL VEIN - MODERATE NARROWING. INTRAVASCULAR ULTRASOUND INTERPRETATION:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13188760 ↗
• InjuryOct 8, 2021Migration; Migration

  STENT MIGRATION FROM RIGHT COMMON FEM TO THE ATRIUM. PATIENT IS STABLE AND NOT SYMPTOMATIC. INFORMATION FROM MEDWATCH REPORT RECEIVED (B)(6) 2021: STENT THAT WAS PLACED IN RIGHT CFV (COMMON FEMORAL VEIN ) WAS FOUND TO HAVE MIGRATED TO THE PATIENT ' S HEART WHEN HE CAME INTO THE HOSPITAL FOR ANOTHER PROCEDURE. HE UNDERWENT VENOGRAM FOR EVALUATION OF THE LEFT ILIAC VENOUS SYSTEM WHEN HIS RIGHT COMMON ILIAC VEIN STENT WAS OBSERVED WITHIN THE RIGHT ATRIUM. CARDIOTHORACIC SURGERY AND CARDIOLOGY WERE CONSULTED WHO RECOMMENDED EVALUATION WITH ECHOCARDIOGRAPHY. THIS WAS OBTAINED AND THE PATIENT IS NOW BEING ADMITTED FOR OBSERVATION OVERNIGHT .

  Patient problems: Insufficient Information

  MAUDE report 12597930 ↗
• InjuryOct 8, 2021Migration; Migration

  STENT MIGRATION FROM RIGHT COMMON FEM TO THE ATRIUM. PATIENT IS STABLE AND NOT SYMPTOMATIC. INFORMATION FROM MEDWATCH REPORT RECEIVED 01-OCT-21: STENT THAT WAS PLACED IN RIGHT CFV (COMMON FEMORAL VEIN ) WAS FOUND TO HAVE MIGRATED TO THE PATIENT ' S HEART WHEN HE CAME INTO THE HOSPITAL FOR ANOTHER PROCEDURE. HE UNDERWENT VENOGRAM FOR EVALUATION OF THE LEFT ILIAC VENOUS SYSTEM WHEN HIS RIGHT COMMON ILIAC VEIN STENT WAS OBSERVED WITHIN THE RIGHT ATRIUM. CARDIOTHORACIC SURGERY AND CARDIOLOGY WERE CONSULTED WHO RECOMMENDED EVALUATION WITH ECHOCARDIOGRAPHY. THIS WAS OBTAINED AND THE PATIENT IS NOW BEING ADMITTED FOR OBSERVATION OVERNIGHT .

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12596645 ↗
• MalfunctionSep 21, 2021Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  THE TIP SEEMED TO BE BROKEN. OBSERVED THAT WHEN THEY OPENED HTE PACKAGE AND REMOVED THE DEVICE TO PLACE ON THE TABLE. CUSTOMER BELIEVES IT WAS LIKE THIS WHEN THEY OPENED THE PACKAGE. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? N/A NOT USED. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? N/A NOT USED. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? N/A NOT USED. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? N/A NOT USED. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? N/A NOT USED. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12504408 ↗
• InjuryJun 23, 2021Break; Activation, Positioning or Separation Problem; Material Twisted/Bent; Break; Activation, Positioning or Separation Problem; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047438 ↗
• InjuryJun 21, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  COMPLAINT RECEIVED FROM DM VIA E-MAIL ON 25MAY2021--DID 28MAY2021. AS REPORTED TO CUSTOMER RELATIONS: "A PHYSICIAN WAS PERFORMING A VENOUS INTERVENTION AND HAD AN ISSUE WITH THE DEPLOYMENT OF OUR ZILVER VENA STENT. AS HE WAS TRYING TO DEPLOY THE STENT, THE SILVER HANDLE SEEMED TO HAVE FRICTION AND/OR GOT CAUGHT ON SOMETHING WITHIN THE DEPLOYMENT CATHETER AS HE WAS TRYING TO PIN/PULL. THIS CAUSED THE STENT TO JUMP FURTHER TOWARD THE IVC THAN THE PHYSICIAN WOULD HAVE LIKED. WHEN HE REMOVED THE STENT FROM THE PATIENT AND PLACED IT ON THE TABLE, HE WAS STILL ABLE TO REPLICATE THE ISSUE AND THE HANDLE WAS GETTING CAUGHT ON SOMETHING WHEN PUSHING IT IN AND OUT OF THE SYSTEM. (B)(4). LOT- C1770415. ACCESS SITE- LEFT COMMON FEMORAL VEIN. DEPLOYMENT SITE- LEFT COMMON ILIAC VEIN . DUE TO THIS DEPLOYMENT ISSUE, PHYSICIAN FELT IT WAS NECESSARY TO PLACE ANOTHER KISSING ILIAC STENT ON THE RIGHT SIDE. THEY WILL NOT BE REPORTING TO FDA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033894 ↗
• InjuryJun 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PER REP - (B)(6) 2021 - THE STENT ELONGATED UPON DEPLOYMENT. THEY HAD TO PUT ANOTHER SHORTER STENT INSIDE THE FIRST STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. GENERAL QUESTIONS FOR COMPLAINT OCCURRING DURING USE, REQUEST THE FOLLOWING: WHERE WAS THE ACCESS SITE? LEFT COMMON FEMORAL VEIN. WHAT WAS THE PATIENT¿S ANATOMY? (I.E. SCARRED, TORTUOUS, CALCIFIED, ETC.) CALCIFIED. WHAT WAS THE TARGET LOCATION FOR THE STENT? COMMON ILIAC VEIN. WAS THE TARGET LOCATION SEVERELY CALCIFIED OR TORTUOUS? CALCIFIED. WAS THE DEVICE FLUSHED PRIOR TO USE? YES. WERE THERE ANY DIFFICULTIES DEPLOYING THE STENT? YES. PHYSICIAN MET WITH QUITE A BIT OF RESISTANCE UPON UNSHEATHING/DELIVERING THE STENT. WAS THE STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959214 ↗
• InjuryMay 11, 2021Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION, DEVICE EVALUATION AND RECEIPT OF IMAGE REVIEW. ADDITIONAL INFORMATION RECEIVED 14-MAY-2021: ANSWERS TO THE FOLLOWING QUESTIONS WERE PROVIDED BY THE REP VIA PHONE ON 14MAY2021. -MS 14MAY2021 1. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? N/A, YES, NO -NO 2. WAS THE DEVICE USED PERCUTANEOUSLY? N/A,YES,NO -YES 3. WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL -IPSILATERAL 4. IT IS NOTED THAT THE PHYSICIAN MET WITH QUITE A BIT OF RESISTANCE UPON UNSHEATHING/DELIVERING THE STENT, HOW DID THE PHYSICIAN ADDRESS THIS? -THEY PAUSED AND CONTINUED TO DEPLOY. 5. DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? N/A, YES, NO -YES 6. WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A, YES, NO -YES 7. WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? N/A, YES, NO -NO 8. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO -NO 9. PLEASE SPECIFY IF YES. -N/A. DEVICE WAS EVALUATED ON 26-MAY-2021. THE OUTER SHEATH OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805508 ↗