Zilver 518 G43773Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002437736), received between Jun 22, 2016 and Apr 20, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Off-Label Use; Off-Label Use

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A LEFT LEG PTA AND STENT PLACEMENT PROCEDURE IN WHICH THE ZILVER 518 VASCULAR SELF-EXPANDING STENT, G43773, WAS USED. THE PHYSICIAN GAINED ACCESS VIA THE RIGHT GROIN AND WENT CONTRALATERAL TO THE LEFT LEG. WHILE ATTEMPTING TO DEPLOY AND PLACE STENT THE FLEXOR MATERIAL CAME OFF OF THE HANDLE. THE DEVICE WAS REMOVED FROM THE PATIENT, NO STENT WAS DEPLOYED, AND OPENED ANOTHER OF THE SAME DEVICE TO COMPLETE THE 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. PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775221 ↗
• MalfunctionAug 19, 2022Off-Label Use; Off-Label Use

  WHEN PINNED AND PULLED, THE STENT FLOWERED OUT, BUT THE LAST 1 CM OF THE STENT WOULD NOT EXIT OUT. THE DEVICE WAS COMPLETELY PULLED BACK TO THE HUB. THE STENT SHOULD HAVE COMPLETELY DEPLOYED AT THIS POINT. THE USER PULLED THE WHOLE DEPLOYMENT SYSTEM BACK TO DEPLOY STENT IN TARGET SITE. THIS OCCURRED WITH EVERY STENT USED IN THIS CASE: PR357037 ¿ G43773, LOT NUMBER: C1753166, PR357039 ¿ G43773, LOT NUMBER: C1794186, PR357040 ¿ G43773, LOT NUMBER: C1633402, PR357041 ¿ G36048, LOT NUMBER: C1778086, PR357042 ¿ G36048, LOT NUMBER: C1810418. 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? NA. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 5 FR TERUMO SLENDER SHEATH DID THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257546 ↗
• MalfunctionAug 19, 2022Off-Label Use; Off-Label Use

  WHEN PINNED AND PULLED, THE STENT FLOWERED OUT, BUT THE LAST 1 CM OF THE STENT WOULD NOT EXIT OUT. THE DEVICE WAS COMPLETELY PULLED BACK TO THE HUB. THE STENT SHOULD HAVE COMPLETELY DEPLOYED AT THIS POINT. THE USER PULLED THE WHOLE DEPLOYMENT SYSTEM BACK TO DEPLOY STENT IN TARGET SITE. THIS OCCURRED WITH EVERY STENT USED IN THIS CASE: (B)(6)¿ G43773, LOT NUMBER C1753166. (B)(6)¿ G43773, LOT NUMBER C1794186. (B)(6)¿ G43773, LOT NUMBER C1633402. (B)(6)¿ G36048, LOT NUMBER C1778086. (B)(6)¿ G36048, LOT NUMBER C1810418. 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? NA. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 5 FR TERUMO SLENDER SHEATH. DID THE PATIENT REQUIRE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257508 ↗
• MalfunctionAug 19, 2022Off-Label Use; Off-Label Use

  WHEN PINNED AND PULLED, THE STENT FLOWERED OUT, BUT THE LAST 1 CM OF THE STENT WOULD NOT EXIT OUT. THE DEVICE WAS COMPLETELY PULLED BACK TO THE HUB. THE STENT SHOULD HAVE COMPLETELY DEPLOYED AT THIS POINT. THE USER PULLED THE WHOLE DEPLOYMENT SYSTEM BACK TO DEPLOY STENT IN TARGET SITE. THIS OCCURRED WITH EVERY STENT USED IN THIS CASE: (B)(4) ¿ G43773, LOT NUMBER C1753166, (B)(4) ¿ G43773, LOT NUMBER C1794186, (B)(4) ¿ G43773, LOT NUMBER C1633402, (B)(4) ¿ G36048, LOT NUMBER C1778086, (B)(4) ¿ G36048, LOT NUMBER C1810418. 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? NA. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 5 FR TERUMO SLENDER SHEATH. DID THE PATIENT REQU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257479 ↗
• MalfunctionNov 3, 2021Off-Label Use; Off-Label Use

  ***COMBINED INITIAL AND FINAL MDR BEING SUBMITTED*** PER REP - 09FEB2021 - THEY PUT THE DEVICE IN THROUGH THE ACCESS SHEATH. IT WAS STIFF GOING IN. THE SHEATH ITSELF CAME DETACHED FROM THE HUB. THEY HAD NOT DEPLOYED THE STENT YET. THEY REMOVED BOTH PARTS OF THE SHEATH TOGETHER AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. LAB EVALUATION COMPLETED ON (B)(6) 2021, THE FOLLOWING WAS NOTED: "OUTER SHEATH AT WHITE CONNECTOR CAP AT DISTAL END OF THE HANDLE". CONFIRMATION OF OFF-LABEL USE RECEIVED 06-OCT-2021: THE IFU STATES THAT '¿THE ZILVER VASCULAR STENT IS INTENDED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES''. THE USER USED THIS DEVICE FOR THE TREATMENT OF A LESION ON THE SFA. THIS IS CONSIDERED OFF LABEL USE 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?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743630 ↗
• MalfunctionJun 11, 2020Premature Activation; Off-Label Use; Activation, Positioning or Separation Problem; Premature Activation; Off-Label Use; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO IMAGING REVIEW BEING COMPLETED ON (B)(6) 2020. PER REP - (B)(6) 2020 - I HAD A CASE AT WOMACK ((B)(4)) THIS AM WITH DR. (B)(6) AND A 6X80 ZILVER518 DEPLOYED IN ON ITSELF. USED A 6X100 VIABAHN THROUGH THE SUPER TIGHT HORRIBLE STENT MALFUNCTION AND THEN USED A 6X40 DORADO TO RUPTURE THE STENT INSIDE THE STENT.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10146062 ↗
• MalfunctionJun 22, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IMAGES RECEIVED AS A RESULT OF REPORT # 3001845648-2016-00140 CONFIRMED THAT AN ADDITIONAL ZILVER STENT ALSO PLACED DURING THE PROCEDURE WAS CONFIRMED TO HAVE SHORTENED ON DEPLOYMENT. THE STENT REMAINS IMPLANTED IN THE PATIENT. FDA MDR REPORTING REQUIRED BASED ON THE REPORTING MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY FOR THE MALFUNCTION ' STENT SHORTENING ON DEPLOYMENT'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5740955 ↗