PROMUS Element™ Plus H7493911432220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807803), received between Mar 29, 2018 and Mar 29, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT JAILING OCCURRED. IN (B)(6) 2013, THE PATIENT WAS REFERRED FOR EMERGENT CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE THIRD OBTUSE MARGINAL BRANCH (OM3) WITH 95% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X32MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. AFTER DEPLOYMENT OF STUDY STENT IN OM3, JAILING WAS OBSERVED IN OM2 EXTENDING UP THROUGH MID LEFT CIRCUMFLEX ARTERY. IT WAS REPORTED THAT OM2 WAS JAILED APPROXIMATELY WITH 50% OSTIAL STENOSIS. GIVEN THE COMPLEXITY OF THE PROCEDURE AND THE RESTORATION OF TIMI 3 FLOW POST THE PROCEDURE, NO INTERVENTION WAS PERFORMED IN RESPONSE TO JAILING. TARGET LESION #2 WAS A DE NOVO LONG LESION LOCATED FROM PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) TO DISTAL LCX WITH 100% STENOSIS AND WAS 26MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.00MM. TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.25X28MM PROMUS ELEMENT¿ PLUS STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS A DE NOVO LON

  Patient problems: Obstruction/Occlusion

  MAUDE report 7382946 ↗