BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4937765 · Received July 23, 2015

    Report

    Report Number
    2134265-2015-04746
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 26, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LONGITUDINAL STENT COMPRESSION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL AND RIGHT FEMORAL ARTERY. THERE WERE BITRUNCAL LESIONS. THE FIRST LESION WAS A 70-90% STENOSED, 3-5MM IN REFERENCE DIAMETER LESION THAT WAS LOCATED IN THE VERY CALCIFIED COMMON CORE WITH A NORMAL CORONARY FLOW (TIMI 3). THE SECOND LESION WAS A 50-70% STENOSED, TYPE B1 LESION (FOCAL TYPE LESION INVOLVING THE BODY OF A STENT) WITH A REFERENCE DIAMETER OF 3MM THAT WAS LOCATED IN THE VERY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WITH A NORMAL CORONARY FLOW (TIMI 3). A 3.5 7F SG EBU NON-BSC GUIDE CATHETER WAS PLACED SELECTIVELY AT THE COMMON CORE'S LEVEL WITH SOLID SUPPORT. A 0.0144 180CM NON-BSC GUIDEWIRE WAS ADVANCED EASILY ACROSS THE LESION AND WAS PLACED DOWNSTREAM TO THE MEDIAL LEFT CIRCUMFLEX ARTERY (LCX). ANOTHER 0.014 190CM NON-BSC GUIDEWIRE WAS ADVANCED WITH DIFFICULTIES AND WAS PLACED DOWNSTREAM IN THE ANTERIOR INTERVENTRICULAR ARTERY. A 3.0X15MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED AND INFLATED 18 ATMS FOR 10 SECONDS TO PREDILATE THE COMMON CORE UP TO THE PROXIMAL ANTERIOR INTERVENTRICULAR ARTERY. A 28X3.50MM PROMUS PREMIER¿ STENT WAS DEPLOYED AT 14 ATMS FOR 10 SEC AT THE COMMON CORE LEVEL. THE STENT DELIVERY BALLOON WAS REINFLATED TO 20 ATMS AT 10 SEC. A 4.0X15MM EMERGE BALLOON CATHETER WAS PLACED AT THE COMMON CORE'S LEVEL AND WAS INFLATED AT 16 ATM FOR 10 SEC. A 0.014 180CM FLOPPY NON-BSC GUIDEWIRE WAS ADVANCED TO CROSS THE LESION AND WAS PLACED DOWNSTREAM THE PROXIMAL LCX. A 3.00X15MM EMERGE BALLOON CATHETER WAS ADVANCED AND PASSED THROUGH THE ENDOSCOPE STRUTS AND WAS PLACED FROM THE COMMON CORE TO THE PROXIMAL LCX. INFLATION WAS PERFORMED AT 16 ATM FOR 10 SECS. THE 3.0X15MM NC QUANTUM APEX MR BALLOON CATHETER WAS PASSED THROUGH THE ENDOSCOPE STRUTS AND WAS PLACED FROM THE COMMON CORE TO THE PROXIMAL ANTERIOR INTERVENTRICULAR ARTERY. INFLATION WAS PERFORMED AT 16 ATM 10 SECS. ANGIOGRAPHIC CHECK REVEALED THE COMMON CORE IS FREE OF SIGNIFICANT LESION. THERE WAS NO SIGN OF VISIBLE DISSECTION. THE CORONARY FLOW WAS NORMAL (TIMI 3) AND THERE WAS NO SPASM INDUCED DURING THE PROCEDURE. HOWEVER, THE PHYSICIAN NOTED A LONGITUDINAL COMPRESSION AT THE PROXIMAL PART OF THE PROMUS STENT IN THE COMMON CORE. THE OSTIUM OF THE COMMON CORE WAS NOT COVERED BY THE STENT. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, FOLLOWED BY OPTICAL COHERENCE TOMOGRAPHY (OCT) TO VISUALIZE THE LONGITUDINAL COMPRESSION WITH PROPER RESIDUAL LIGHT WITHOUT TOUCHING THE OSTIUM OF THE LCX. A 2.50X15MM EMERGE BALLOON CATHETER WAS ADVANCED AND PLACED AT THE MEDIUM ANTERIOR INTERVENTRICULAR ARTERY FOR PREDILATION. THREE DILATIONS WERE PERFORMED AT 16 ATM EACH FOR 30 SECONDS. A 2.5X20MM NC QUANTUM APEX MR WAS PLACED AT THE MEDIUM ANTERIOR INTERVENTRICULAR ARTERY'S LEVEL FOR DILATION. FOUR ADDITIONAL DILATIONS WERE PERFORMED AT 20 ATM FOR 40 SECS. A 3.0X28MM NON-BSC STENT WAS DEPLOYED 10 ATMS FOR 30 SECS AT THE MEDIUM ANTERIOR INTERVENTRICULAR ARTERY'S LEVEL. THE STENT DELIVERY BALLOON WAS REINFLATED AT 14 ATM FOR 10 SECS. ANOTHER 3.50X12MM NON-BSC STENT WAS PLACED AT THE COMMON CORE'S LEVEL AND POST DILATION WAS PERFORMED AT 24 ATM FOR A TOTAL TIME FRAME OF 10 SECONDS. A 4.0X15MM EMERGE BALLOON CATHETER WAS PLACED AT THE COMMON CORE'S LEVEL. DILATION WAS PERFORMED AT 14 ATM FOR 10 SECS. ANOTHER 3.5X20MM QUANTUM APEX MR WAS PLACED AT THE MEDIUM ANTERIOR INTERVENTRICULAR ARTERY'S LEVEL AND DILATION WAS PERFORMED AT 12 ATM FOR 20 SECS. OCT CHECK WAS AGAIN PERFORMED WHICH REVEALED A BAD-APPOSITION OF THE STENT AT THE COMMON CORE'S LEVEL. A 4.5X15MM EMERGE XL BALLOON CATHETER WAS PLACED AT THE COMMON CORE'S LEVEL. DILATION WAS PERFORMED AT 12 ATM FOR 10 SECS. FINAL ANGIOGRAPHIC CHECK REVEALED THE COMMON CORE AND THE MEDIUM ANTERIOR INTERVENTRICULAR ARTERY WERE FREE OF SIGNIFICANT LESION. THERE WERE NO SIGNS OF VISIBLE DISSECTION. NO THROMBUS WAS NOTED. THE CORONARY FLOW WAS NORMAL (TIMI3). NO SPASM WAS INDUCED DURING PROCEDURE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS TRANSFERRED TO ICU FOR SURVEILLANCE FOR 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478412 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925128350 17783502

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention GA BMW 190CM 0.014 GUIDEWIRE| SG EBU 3.5 7F PROBE HOLDER| RUNTHROUGH INTERMEDIATE 0.0144-180 CM GUIDEWIRE| NC QUANTUM APEX MR 3.0-15 MM BALLOON CATHETER| EMERGE 3.00X15MM BALLOON CATHETER| RUNTHROUGH FLOPPY 0.014 180 CM GUIDEWIRE| EMERGE 4.0X15MM BALLOON CATHETER