Promus PREMIER™ H7493952824270Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729844846), received between Dec 2, 2016 and Jun 11, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75X24MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE. THE STENT WAS CRIMPED WHEN IT WAS TAKEN OUT OF STERILE PACKAGING/ HOOP. HOWEVER, IT WAS NOTED THAT THE STENT ARCHITECTURE WAS COMPROMISED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8689842 ↗
• MalfunctionNov 1, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 24 MM PROMUS PREMIER WAS ADVANCED INTO A WATCHDOG HEMOSTASIS VALVE AND RESISTANCE WAS FELT WHICH DESTROYED THE DISTAL END OF THE STENT. THE STENT DID NOT ENTER THE PATIENT'S BODY. THE WATCHDOG WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8029015 ↗
• MalfunctionMay 24, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 2.75 X 24MM PROMUS PREMIER¿ STENT, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75 X 24MM PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7541579 ↗
• MalfunctionMar 6, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75X24MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. DURING PREPARATION, UPON LOADING THE DEVICE, IT WAS NOTED THAT THE STENT HAD KINKS. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7317270 ↗
• MalfunctionDec 20, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.75X24MM PROMUS PREMIER STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SHAFT BROKE UPON DELIVERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6189328 ↗
• InjuryDec 2, 2016Bent; Break; Difficult to Remove; Bent; Break; Difficult to Remove

  IT WAS REPORTED THAT STENT DAMAGE, SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED. THE IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). A 6FR FR4 GUIDE CATHETER WITH SIDEHOLES WAS USED TO THE ENGAGE THE RCA, A NON-BSC CORONARY WIRE WAS ADVANCED INTO THE DISTAL RCA. THE ISR MID RCA LESION WAS PRE-DILATED WITH A 2.5X15MM EMERGE BALLOON CATHETER AT 9 ATMOSPHERES IMPROVING FLOW TO THE DISTAL VESSEL. A 2.25X18MM NON-BSC STENT WAS ADVANCED BUT WOULD NOT CROSS THE EDGE OF THE PREVIOUSLY PLACED MID TO PROXIMAL RCA STENT. A 2.25X16MM PROMUS PREMIER DRUG-ELUTING STENT (DES) WAS ABLE TO CROSS THE PROXIMAL STENT WHICH WAS DEPLOYED AT 11 ATMOSPHERES. THE RESIDUAL DISTAL LESION, PROXIMAL TO THE DISTAL STENT WAS TREATED WITH A 2.25X12MM PROMUS PREMIER DES DEPLOYED AT 12 ATMOSPHERES. THE OVERLAPPING SEGMENT WAS POST DILATED WITH THE STENT BALLOON AT 13 ATMOSPHERES. THE REMAINING MID TO PROXIMAL RCA LESION WHICH WAS A LONG SEGMENT OF DISEASE WAS TREATED WITH TWO SEPARATE STENTS DUE TO CROSSABILITY. THE REMAINING MID TO DISTAL SEGMENT OF THE ARTERY WAS STENTED WITH A 2.5X24MM PROMUS PREMIER DES AT 16 ATMOSPHERES. THE PROXIMAL TO MID LESION WAS THEN STE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6142324 ↗