Zilver 635 G43841Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002438412), received between Jun 15, 2021 and Jun 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAS HAD NUMEROUS CTS AND A TOTAL OF 4 SECONDARY INTERVENTIONS THROUGHOUT PARTICIPATION IN THIS STUDY. TO SIMPLIFY THESE CTS (AS RELATED TO THIS EVENT), PLEASE SEE THE TABLE UPLOADED AS AN ATTACHED FILE THE TABLE PROVIDES THE DATE OF THE IMAGING, THE NUMBER OF DAYS POST-PROCEDURE, THE MAXIMUM ANEURYSM DIAMETER AND PRESENCE OF AN ENDOLEAK (AS REPORTED BY THE CLINICAL STUDY SITE OR THE CORE LABORATORY). ALSO INCLUDED IS THE SECONDARY INTERVENTIONS, THE INDICATION FOR THEM AND THE TREATMENTS. A CT DATED (B)(6) 2021 REVEALED AN ENLARGING ANEURYSM. THE CLINICAL STUDY SITE WAS UNABLE TO IDENTIFY AN ENDOLEAK AND REPORTED THE MAXIMUM ANEURYSM DIAMETER WAS 73MM. THE CORE LABORATORY EVALUATION OF THE CT IDENTIFIED A DEFINITE ENDOLEAK BUT THE SOURCE COULD NOT BE DETERMINED AND WAS LISTED AS AN UNKNOWN ENDOLEAK. A SECOND CT SCAN DATED (B)(6) 2021 WAS COMPLETED. THE SITE AGAIN COULD NOT IDENTIFY AN ENDOLEAK, BUT CONTINUED ANEURYSM ENLARGEMENT, NOW 77MM, LED THE SITE TO SCHEDULE A SECONDARY INTERVENTION. CORE LABORATORY EVALUATION OF THE CT AGAIN REVEALED AN UNKNOWN TYPE ENDOLEAK. ON (B)(6) 2021 (1705 DAYS POST-PROCEDURE) THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO PLACE A PROX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999836 ↗
• InjuryJun 15, 2021Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAS HAD NUMEROUS CTS AND A TOTAL OF 4 SECONDARY INTERVENTIONS THROUGHOUT PARTICIPATION IN THIS STUDY. TO SIMPLIFY THESE CTS (AS RELATED TO THIS EVENT), PLEASE SEE THE TABLE UPLOADED AS AN ATTACHED FILE THE TABLE PROVIDES THE DATE OF THE IMAGING, THE NUMBER OF DAYS POST-PROCEDURE, THE MAXIMUM ANEURYSM DIAMETER AND PRESENCE OF AN ENDOLEAK (AS REPORTED BY THE CLINICAL STUDY SITE OR THE CORE LABORATORY). ALSO INCLUDED IS THE SECONDARY INTERVENTIONS, THE INDICATION FOR THEM AND THE TREATMENTS. A CT DATED (B)(6) 2021 REVEALED AN ENLARGING ANEURYSM. THE CLINICAL STUDY SITE WAS UNABLE TO IDENTIFY AN ENDOLEAK AND REPORTED THE MAXIMUM ANEURYSM DIAMETER WAS 73MM. THE CORE LABORATORY EVALUATION OF THE CT IDENTIFIED A DEFINITE ENDOLEAK BUT THE SOURCE COULD NOT BE DETERMINED AND WAS LISTED AS AN UNKNOWN ENDOLEAK. A SECOND CT SCAN DATED (B)(6) 2021 WAS COMPLETED. THE SITE AGAIN COULD NOT IDENTIFY AN ENDOLEAK, BUT CONTINUED ANEURYSM ENLARGEMENT, NOW 77MM, LED THE SITE TO SCHEDULE A SECONDARY INTERVENTION. CORE LABORATORY EVALUATION OF THE CT AGAIN REVEALED AN UNKNOWN TYPE ENDOLEAK. ON (B)(6) 2021 (1705 DAYS POST-PROCEDURE) THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO PLACE A PROX

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 11999015 ↗