Zilver Vena G57449Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10827002574493), received between Feb 11, 2021 and Jul 7, 2023 — classified as 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNDISCLOSED PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449, WAS USED. THE STENT WAS DEPLOYED IN A TIGHT LESION. WHEN DEPLOYED THE STENT STRETCHED TO 200 CM FROM A 160CM LENGTH. WHEN IT DEPLOYED IT WENT INTO THE TISSUE TRACT OF THE PATIENT. THE PATIENT WAS TRANSFERRED FROM THE FACILITY TO THE HOSPITAL WITH AN EMERGENT PROCEDURE. AS PER CLINICAL SPECIALIST AT COOK INC RECEIVED 19-NOV-21: THE DOCTOR DID NOT OBSERVE THE STENT DETACH FROM THE DELIVERY CATHETER (RUSHING) AND PULLED THE STENT AND STRETCHED IT. THE PATIENT HAD TO GO TO THE HOSPITAL FOR EMERGENCY REMOVAL OF THE STENT. THIS FILE WILL CAPTURE THE USER ERROR OF AN INCORRECT SIZE ACCESS SHEATH USED. A 9FR ACCESS SHEATH WAS USED INSTEAD OF A 7FR. PER MANUFACTURE REQUEST THIS FILE WAS OPENED IN RELATION TO PR341184- STENT STRETCHED WHEN DEPLOYED, TO CAPTURE THE USER ERROR OF AN INCORRECT SIZE ACCESS SHEATH USED (B)(6) 2023. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276915 ↗
• InjuryJul 6, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNDISCLOSED PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449, WAS USED. THE STENT WAS DEPLOYED IN A TIGHT LESION. WHEN DEPLOYED THE STENT STRETCHED TO 200 CM FROM A 160CM LENGTH. WHEN IT DEPLOYED IT WENT INTO THE TISSUE TRACT OF THE PATIENT. THE PATIENT WAS TRANSFERRED FROM THE FACILITY TO THE HOSPITAL WITH AN EMERGENT PROCEDURE. AS PER CLINICAL SPECIALIST AT COOK INC RECEIVED 19-NOV-21: THE DOCTOR DID NOT OBSERVE THE STENT DETACH FROM THE DELIVERY CATHETER (RUSHING) AND PULLED THE STENT AND STRETCHED IT. THE PATIENT HAD TO GO TO THE HOSPITAL FOR EMERGENCY REMOVAL OF THE STENT. THIS FILE WILL CAPTURE THE USER ERROR OF AN INCORRECT SIZE ACCESS SHEATH USED. A 9FR ACCESS SHEATH WAS USED INSTEAD OF A 7FR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17268403 ↗
• MalfunctionMay 11, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910668 ↗
• MalfunctionMay 4, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  PER EMAIL: A PATIENT HAD FAILED ANTICOAGULATION AND THROMBECTOMY TWICE AND WAS COMING BACK FOR MECHANICAL THROMBECTOMY AND STENT PLACEMENT DUE TO MAY THURNER. AFTER REMOVING ALL THE CLOT, WE MEASURED THE VESSEL WITH IVUS AND PLACED A 16X140 VENA. UNFORTUNATELY, THE STENT WAS SO COMPRESSED THAT ON A LATERAL PROJECTION, IT WAS MEASURING 23MM IN DIAMETER. WE PRE DILATED WITH A 12MM BALLOON AND POST DILATED WITH A 14MM BALLOON BUT THAT DIDN¿T SEEM TO HELP. THE PATIENT RECEIVED AND SECOND STENT, 16X80 ABRE, TO HELP OPEN THE VESSEL. THIS PROVIDED SATISFACTORY RESULTS. THIS FILE WILL CAPTURE THE USE OF A 8FR ACCESS SHEATH IN THE PROCEDURE RELATED TO PR 389608 / MDR REF#3001845648-2023-00180. 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, AN ADDITIONAL STENT JUST HAD TO BE PLACED. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16866954 ↗
• MalfunctionApr 3, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  PER REP 11MAR2021: AFTER THE PHYSICIAN DEPLOYED THE STENT IN THE LEFT ILIAC, THE 1ST 75 % OF THE PROXIMAL STENT DEPLOYED WELL AND FULLY OPEN. THEN THE DISTAL 25 % OF THE STENT DID NOT FULLY OPEN AND REMAINED COMPRESSED. AFTER SEEING THIS, THE PHYSICIAN TRIED TO BALLOON THAT PART OF THE STENT MULTIPLE TIMES BUT EACH TIME, AFTER BALLOONING, THE STENT WOULD JUST COMPRESS AGAIN. AFTER THIS, THE PHYSICIAN HAD TO LINE THE INSIDE OF THE STENT WITH A COMPETITIVE STENT. 8FR SHEATH USED RATHER THAN THE RECOMMENDED 7FR NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS OCCURRENCE EXAMPLES OF RPN PREFIXES (BUT NOT LIMITED TO): ZIB5, ZIB6, ZIV5, ZISV6, ZVT7, ZIV6. GENERAL QUESTIONS FOR COMPLAINT OCCURRING DURING USE, REQUEST THE FOLLOWING: WHERE WAS THE ACCESS SITE?: LEFT GROIN. WHAT WAS THE PATIENT¿S ANATOMY? I.E. SCARRED, TORTUOUS, CALCIFIED, ETC.: SOMEWHAT TORTUOUS, POSSIBLY SCARRED. WHAT WAS THE TARGET LOCATION FOR THE STENT?: LEFT ILIAC. WAS THE TARGET LOCATION SEVERELY CALCIFIED OR TORTUOUS?: TORTUOUS. WAS THE DEVICE FLUSHED PRIOR TO USE?: YES. WERE THERE ANY DIFFICULTIES DEPLOYING THE STENT?: NO. WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT?: YES. WHAT OT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662887 ↗
• InjuryApr 3, 2023No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B) (6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662688 ↗
• InjuryMar 31, 2023Migration; Migration

  PER REP - (B)(6) 2023 - LEFT ACCESS. MID FEMORAL VEIN. THEY STENTED THE LEFT ILIAC VEIN DUE TO MAY THURNER SYNDROME. THE STENT ENDED UP MIGRATING DUE TO ADDITIONAL PRODUCT BEING INSERTED INTO THE BODY FOR THE PROCEDURE. THEY WERE ABLE TO FIXATE THE STENT AT THE COMPRESSION POINT AND THEY LAID ANOTHER STENT IN TO PREVENT MIGRATION. PER REP - (B)(6) 2023 - SCHEDULED UNILATERAL VENOGRAM WITH POSSIBLE STENT. ACCESS TO LEFT MID FEMORAL VEIN WITH 9FR SHEATH. IVUS AND PRE-BALLOON ANGIOPLASTY WAS USED. PHYSICIAN WENT AHEAD AND STENTED WITH A 16X140 ZILVER VENA IN THE LEFT COMMON ILIAC VEIN AND PLANNED TO EXTEND WITH A 20 Z STENT INTO THE IVC. WHILE INTRODUCING THE Z STENT INTRODUCER INTO THE BODY, THE PATIENT MOVED ON THE TABLE. THE WIRE WAS PULLED BACK AND MISPLACED DUE TO THE PATIENT MOVING. WHEN USING FLUORO WATCHING THE Z STENT INTRODUCER ADVANCE, I NOTICED THAT THE ZILVER VENA STENT HAD SHIFTED UP INTO THE IVC AND IT LOOKED LIKE THE WIRE WAS GOING THROUGH THE STRUT OF THE STENT AND THE Z STENT INTRODUCER ¿ I HAD TOLD THE PHYSICIAN TO STOP WHAT HE WAS DOING SO THAT WOULD NOT ADVANCE THE STENT ANY FURTHER. WE CAREFULLY PLANNED OUT WHAT WE WERE GOING TO DO NEXT TO GET THE STENT LOWER INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655785 ↗
• MalfunctionMar 22, 2023Off-Label Use; Deformation Due to Compressive Stress; Off-Label Use; Deformation Due to Compressive Stress

  SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 16 JUNE 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589026 ↗
• 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. 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 THIRD STENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883507 ↗
• 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 (SUBJECT OF THIS REPORT). 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. D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854479 ↗
• InjuryApr 21, 2022Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE: A (B)(6) MALE PATIENT UNDERWENT A REVASCULARIZATION OF A FEMORAL VENOUS LESION IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449, WAS USED. THE PHYSICIAN DEPLOYED THE STENT, THEN SAW VIA FLUOROSCOPY THAT 2-3CM LENGTHWISE IN THE MIDDLE PORTION OF THE STENT WAS TWISTED. ATTEMPT TO DILATE WITH A 14MM BALLOON. THE BALLOON GOT CAUGHT ON THE STENT AND POPPED AND WAS STUCK ON STENT. APPROXIMATELY AFTER NINETY MINUTES OF TRYING THE PHYSICIAN WAS ABLE TO GET THE BALLOON OUT. PHYSICIAN THEN DEPLOYED A 14MM CORDIS STENT INSIDE OF THE ZILVER STENT AND POST DILATED BUT WAS ABLE TO ONLY DILATE STENT LUMEN OPEN TO 8MM OF THE INTENDED 14MM. THE PATIENT DID WELL AND PHYSICIAN DETERMINED THIS WAS ENOUGH FLOW THROUGH THE STENT TO SATISFACTORY AND WILL CONTINUE TO MONITOR FOR THE NEXT SEVERAL MONTHS. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166893 ↗
• InjuryApr 20, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ACCORDING TO THE INITIAL REPORTER: A (B)(6) MALE PATIENT UNDERWENT A REVASCULARIZATION OF A FEMORAL VENOUS LESION IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449, WAS USED. THE PHYSICIAN DEPLOYED THE STENT, THEN SAW VIA FLUOROSCOPY THAT 2-3CM LENGTHWISE IN THE MIDDLE PORTION OF THE STENT WAS TWISTED. ATTEMPT TO DILATE WITH A 14MM BALLOON. THE BALLOON GOT CAUGHT ON THE STENT AND POPPED AND WAS STUCK ON STENT. APPROXIMATELY AFTER NINETY MINUTES OF TRYING THE PHYSICIAN WAS ABLE TO GET THE BALLOON OUT. PHYSICIAN THEN DEPLOYED A 14MM CORDIS STENT INSIDE OF THE ZILVER STENT AND POST DILATED BUT WAS ABLE TO ONLY DILATE STENT LUMEN OPEN TO 8MM OF THE INTENDED 14MM. THE PATIENT DID WELL AND PHYSICIAN DETERMINED THIS WAS ENOUGH FLOW THROUGH THE STENT TO SATISFACTORY AND WILL CONTINUE TO MONITOR FOR THE NEXT SEVERAL MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159404 ↗
• MalfunctionMar 15, 2022Break; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Break; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  PER REP (B)(6) 2022 - PROCEDURE- INTERVENTION OF THE RIGHT COMMON ILIAC VEIN, ACCESSED THE RIGHT GROIN, USED A 10F TERUMO SHORT SHEATH AND AN 035 WIRE. COMPLAINT- AFTER FULLY DEPLOYING THE STENT, THE PHYSICIAN NOTICED THAT THE STENT JUMPED SLIGHTLY UP TOWARD THE IVC. UPON CLOSER EXAMINATION, IT LOOKS LIKE THE STENT CELLS FLARED OR SEPARATED FROM THE STRUTS AT THE CRANIAL END. IVUS WAS PERFORMED TO SEE THAT THE CRANIAL END WAS MEASURING CLOSE TO 18MM IN DIAMETER, WHICH CONFIRMED THAT THE STENT CELLS OPENED/SEPARATED FROM EACH OTHER, FLARING OUT TO A LARGER DIAMETER THAN THE ORIGINAL 16 MM. I HAVE ATTACHED VIDEOS OF THE IMAGES WE TOOK POST DEPLOYMENT. POST DILATATION WAS PERFORMED WITH AN ATLAS 16X60 BALLOON. NO EVIDENT HARM DONE TO PATIENT AS OF NOW. I ASKED THE PHYSICIAN IF HE THOUGHT THE STENT CELLS GOT CAUGHT ON THE BILATERAL STENT (LEFT SIDE), STRETCHING IT APART, BUT HE DID NOT THINK SO. PHYSICIAN WOULD LIKE A FOLLOW UP TO DETERMINE THE CAUSE. HE WILL NOT BE REPORTING TO FDA. NO ADDITIONAL INTERVENTION HAD TO BE DONE AS OF YET AFTER THIS ISSUE. 6.3.1.1 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO IF YES, PLEASE DESCRIBE. 6.3.1.2 WAS THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770280 ↗
• InjuryMar 1, 2022Migration; Migration

  ACCORDING TO THE INITIAL REPORTER: "TODAY I WAS MADE AWARE OF AN INCIDENT THAT OCCURRED AS A RESULT OF A ZILVER VENA C57449 (16X140) STENT THAT WAS PLACED BY (SURGEON)L AT C43414-4 ON (B)(6) 2022. THE STENT WAS PLACED VIA FEMORAL ACCESS WITHOUT INCIDENT HOWEVER UPON ARRIVAL HOME THE PATIENT EXPERIENCED SHORTNESS OF BREATH. HE WAS SENT TO THE HOSPITAL WHERE IT WAS DETERMINED THAT THE STENT HAD MIGRATED TO THE PATIENT¿S LUNGS. AN EMERGENCY SURGICAL PROCEDURE WAS PERFORMED BY A CARDIOTHERACIC SURGEON TO REMOVE THE STENT. ADDITIONAL SUBSEQUENT PROCEDURES MAY ALSO NEED TO BE PERFORMED HOWEVER THE PATIENT IS STABLE AND WALKING AROUND POST SURGERY."

  Patient problems: Foreign Body Embolism

  MAUDE report 13633333 ↗
• InjuryMar 1, 2022Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  COMPLAINT RECEIVED FROM DM VIA E-MAIL ON 31JAN2022--DID 02FEB2022. AS REPORTED TO CUSTOMER RELATIONS: "TODAY I WAS MADE AWARE OF AN INCIDENT THAT OCCURRED AS A RESULT OF A ZILVER VENA C57449 (16X140) STENT THAT WAS PLACED BY DR. (B)(6) AT C43414-4 ON (B)(6) 2022. THE STENT WAS PLACED VIA FEMORAL ACCESS WITHOUT INCIDENT HOWEVER UPON ARRIVAL HOME THE PATIENT EXPERIENCED SHORTNESS OF BREATH. HE WAS SENT TO THE HOSPITAL WHERE IT WAS DETERMINED THAT THE STENT HAD MIGRATED TO THE PATIENT¿S LUNGS. AN EMERGENCY SURGICAL PROCEDURE WAS PERFORMED BY A CARDIOTHERACIC SURGEON TO REMOVE THE STENT. ADDITIONAL SUBSEQUENT PROCEDURES MAY ALSO NEED TO BE PERFORMED HOWEVER THE PATIENT IS STABLE AND WALKING AROUND POST SURGERY. SENIOR MANAGEMENT AND PRODUCT MANAGEMENT HAVE BEEN AWARE OF THIS INCIDENT AND HAVE BEEN INCLUDED IN THIS MESSAGE. PLEASE REACH OUT WITH ANY QUESTIONS." PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? THE ENTIRE STENT WAS SURGICALLY REMOVED BY A CARDIOTHORACIC SURGEON IN AN EMERGENCY PROCEDURE. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. DI

  Patient problems: Foreign Body Embolism; Stacking Breaths

  MAUDE report 13633194 ↗
• InjuryJan 20, 2022Migration; Migration

  PER REP - 22DEC2021 - AFTER DEPLOYING IN THE RIGHT SPOT, WHEN THEY TOOK AN IMAGE USING FLUOROSCOPY, THE STENT HAD SHIFTED. ONE CM OF IT WAS IN THE IVC. THEY HAD DEPLOYED A STENT ON THE OTHER SIDE ALREADY, BUT BECAUSE THIS STENT HAD DEPLOYED IN THE IVC, THEY HAD TO DEPLOY ANOTHER STENT ON THE RIGHT SIDE SO THAT THE STENT WOULD BE KISSING THAT STENT ON THE LEFT SIDE. 6.3.1.1 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO IF YES, PLEASE DESCRIBE. 6.3.1.2 WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? -NO. 6.3.1.3 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -NO IF YES, PLEASE DESCRIBE. 6.3.1.4 DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 6.3.1.5 HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? -NO. 6.3.1.6 HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PREFIX ZVT7: 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO -YES, OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13305379 ↗
• MalfunctionNov 11, 2021Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  A PATIENT OF UNDISCLOSED AGE AND GENDER UNDERWENT A PLACEMENT OF VENA STENT THROUGH RIGHT FEMORAL VEIN APPROACH IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449, WAS USED. CAUDAL PORTION OF STENT FORESHORTENED UPON DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795851 ↗
• MalfunctionOct 13, 2021Structural Problem; Deformation Due to Compressive Stress; Structural Problem; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624511 ↗
• MalfunctionOct 13, 2021Structural Problem; Deformation Due to Compressive Stress; Structural Problem; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624441 ↗
• InjurySep 27, 2021Stretched; Stretched

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNDISCLOSED PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449, WAS USED. THE STENT WAS DEPLOYED IN A TIGHT LESION. WHEN DEPLOYED THE STENT STRETCHED TO 200 CM FROM A 160CM LENGTH. WHEN IT DEPLOYED IT WENT INTO THE TISSUE TRACT OF THE PATIENT. THE PATIENT WAS TRANSFERRED FROM THE FACILITY TO THE HOSPITAL WITH AN EMERGENT PROCEDURE. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES 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 problems: Device Embedded In Tissue or Plaque

  MAUDE report 12533804 ↗
• InjurySep 27, 2021Stretched; Improper or Incorrect Procedure or Method; Stretched; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT REQUIRED TO UPDATE EVENT DESCRIPTION WITH ADDITIONAL INFORMATION RECEIVED ON 19-NOV-21: THE DOCTOR DID NOT OBSERVE THE STENT DETACH FROM THE DELIVERY CATHETER (RUSHING) AND PULLED THE STENT AND STRETCHED IT. THE PATIENT HAD TO GO TO THE HOSPITAL FOR EMERGENCY REMOVAL OF THE STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12533636 ↗
• MalfunctionAug 13, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 21.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317450 ↗
• InjuryAug 10, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299334 ↗
• MalfunctionApr 8, 2021Improper or Incorrect Procedure or Method; Structural Problem; Deformation Due to Compressive Stress; Improper or Incorrect Procedure or Method; Structural Problem; Deformation Due to Compressive Stress

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION ON 07-APR-2021 AS FOLLOWS: THE REP HAS PROVIDED THE ANSWERS TO THE FOLLOWING QUESTIONS. 1. WAS THE DEVICE USED PERCUTANEOUSLY? -YES. 2. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? -GROIN. 3. WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? -CHRONIC OBSTRUCTION . IF OTHER, PLEASE SPECIFY. 4. WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL -IPSILATERAL. 5. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? -YES. 6. DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? -YES. 7. WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? -NO. 8. PLEASE SPECIFY IF YES. -N/A. INITIAL REPORT DETAILS: PER REP - (B)(6) 2021 - AFTER THE PHYSICIAN DEPLOYED THE STENT IN THE LEFT ILIAC, THE 1ST 75 % OF THE PROXIMAL STENT DEPLOYED WELL AND FULLY OPEN. THEN THE DISTAL 25 % OF THE STENT DID NOT FULLY OPEN AND REMAINED COMPRESSED. AFTER SEEING THIS, THE PHYSICIAN TRIED TO BALLOON THAT PART OF THE STENT MULTIPLE TIMES BUT EACH TIME, AFTER BALLOONING, THE STENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 11633771 ↗
• InjuryApr 2, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ACCORDING TO THE INITIAL REPORTER, AFTER THE PHYSICIAN DEPLOYED THE STENT IN THE LEFT ILIAC, THE 1ST 75 % OF THE PROXIMAL STENT DEPLOYED WELL AND FULLY OPEN. THEN THE DISTAL 25 % OF THE STENT DID NOT FULLY OPEN AND REMAINED COMPRESSED. AFTER SEEING THIS, THE PHYSICIAN TRIED TO BALLOON THAT PART OF THE STENT MULTIPLE TIMES BUT EACH TIME, AFTER BALLOONING, THE STENT WOULD JUST COMPRESS AGAIN. AFTER THIS, THE PHYSICIAN HAD TO LINE THE INSIDE OF THE STENT WITH A COMPETITIVE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609682 ↗