BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2112859 · Received June 3, 2011

    Report

    Report Number
    9616099-2011-00383
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT YET BEEN RETURNED. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. CONCOMITANT DEVICES INCLUDE A RINATO GUIDE WIRE, 7F LAUNCHER GUIDE CATHETER, 3.5X15MM I-BP22 BALLOON CATHETER, 3.5X12MM NC VOYAGER BALLOON CATHETER, TERUMO SHEATH, AND 3.5X18MM XIENCE STENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS WAS COMPLETED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE CYPHER SELECT + BALLOON RUPTURED WHILE INFLATED AT 20 ATMS. THERE WAS NO PATIENT INJURY AND THE PRODUCT WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS DESCRIBED AS DE NOVO, 90% STENOSED, WITH HEAVY CALCIFICATION. THE REFERENCE VESSEL WAS MODERATELY TORTUOUS. PRE-DILATION WAS NOT CONDUCTED AND A 3.5X18MM CYPHER SELECT + WAS DIRECTLY DELIVERED TO THE TARGET LESION WITHOUT FRICTION. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE (B)(4) INSTRUCTIONS FOR USE (IFU) WARNS THAT PRIOR TO STENT PLACEMENTS, MAKE CERTAIN TO CARRY OUT PRE-DILATATION OF THE LESION. WHEN THE BALLOON WAS INFLATED UP TO 20ATMS, THE PRESSURE OF THE INFLATION DEVICE SUDDENLY DECREASED AND THE PHYSICIAN CONFIRMED THE BALLOON OF THE CYPHER SELECT + RUPTURED. THE RATED BURST PRESSURE (RBP) INDICATED IN THE IFU IS 16 ATMOSPHERES. THE PRECAUTIONS FOR USE IN THE IFU STATE THAT BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION AND THAT EXCEEDING THE RECOMMENDED RATED BURST PRESSURE (RBP) AS INDICATED ON THE PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. THEREFORE, THE STENT DELIVERY SYSTEM (SDS) OF THE CYPHER SELECT + WAS RETRIEVED AND CHECKED OUTSIDE THE PATIENT. LEAKAGE WAS OBSERVED FROM THE PROXIMAL PORTION OF THE BALLOON. POST-DILATION WITH A NC VOYAGER BALLOON CATHETER WAS CONDUCTED AT 16ATMS TO FURTHER DILATE THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE PHYSICIAN'S COMMENTED THAT "THE BALLOON MIGHT HAVE RUPTURED DUE TO THE CALCIFICATION AT THE TARGET LESION." THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THE DEVICE PREPPED NORMALLY. AN UNKNOWN INDEFLATOR WAS USED. THE SAME INDEFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. THE CONTRAST TO SALINE RATIO WAS 1:1. THE BALLOON RE-WRAPPED PROPERLY. THE BALLOON WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE DURING THE PROCEDURE. THERE WAS NO FRICTION FELT DURING THE DELIVERY. ONE NON-STERILE CYPHER SELECT + (B)(4) 3.50X18MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS ALREADY INFLATED. BLOOD RESIDUES WERE OBSERVED IN THE INFLATION LUMEN AND BALLOON. ONE KINK WAS FOUND AT 24.4 CM FROM DISTAL END; THIS CONDITION ON THE SHAFT COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. NO OTHER DAMAGES WERE FOUND. IN THE FUNCTIONAL ANALYSIS, PRESSURIZED WATER WAS APPLIED TO THE CATHETER USING AN INDEFLATOR, AND LEAKAGE WAS OBSERVED FROM THE INNER BODY AT THE TIP AREA. SEM RESULTS SHOWED THAT THE INNER BODY EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASION. IT IS POSSIBLE THAT THE GUIDEWIRE COULD HAVE PERFORATED THE INNER BODY FROM THE INSIDE TO THE OUTSIDE; HOWEVER, THIS COULD NOT CONCLUSIVELY BE DETERMINED. THE INNER BODY INTERNAL SURFACE EXHIBITED EVIDENCE OF SEVERE AND MULTIPLE ABRASIONS. THE EXACT CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. AN ASSESSMENT WAS PERFORMED BY (B)(4). THE ASSESSMENT CONCLUDED THAT THERE ARE ENOUGH CONTROLS TO DETECT THIS KIND OF ISSUES. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED FAILURE (BALLOON BURST) WAS NOT CONFIRMED; HOWEVER IN THE FUNCTIONAL ANALYSIS, A LEAKAGE WAS OBSERVED FROM THE INNER BODY ON THE TIP AREA; THE EXACT CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOT THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE IS RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15330642 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15330642. PRE-STERILE LOT 15330643 WAS REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NONCONFORMANCE RECORDS AND PROCESS EXCURSIONS WERE ISSUED FOR THIS LOT. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. THE FUNCTIONAL TESTS (MULTIPLE INFLATION AND BURST) AS WELL AS RESULTS FOR LEAK TEST AND 100% INSPECTION WERE REVIEWED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CYPHER SELECT + BALLOON RUPTURED AT 20 ATMS. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS DESCRIBED AS DE NOVO, 90% STENOSED, WITH HEAVY CALCIFICATION. THE REFERENCE VESSEL WAS MODERATELY TORTUOUS. PRE-DILATION WAS NOT CONDUCTED AND A 3.5X18MM CYPHER SELECT + WAS DIRECTLY DELIVERED TO THE TARGET LESION WITHOUT FRICTION. WHEN THE BALLOON WAS INFLATED UP TO 20ATMS, THE PRESSURE OF THE INFLATION DEVICE SUDDENLY DECREASED AND THE PHYSICIAN CONFIRMED THE BALLOON OF THE CYPHER SELECT + RUPTURED. THEREFORE, THE STENT DELIVERY SYSTEM (SDS) OF THE CYPHER SELECT + WAS RETRIEVED AND CHECKED OUTSIDE THE PATIENT. LEAKAGE WAS OBSERVED FROM THE PROXIMAL PORTION OF THE BALLOON. POST-DILATION WITH A NC VOYAGER BALLOON CATHETER WAS CONDUCTED AT 16ATMS TO FURTHER DILATE THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. PHYSICIAN'S COMMENT: THE BALLOON MIGHT HAVE RUPTURED DUE TO THE CALCIFICATION AT THE TARGET LESION, BUT A NC VOYAGER BALLOON CATHETER DID NOT RUPTURE; THEREFORE PRODUCT DEFECT WAS SUSPECTED. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THE DEVICE PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). AN UNKNOWN INDEFLATOR WAS USED. THE SAME INDEFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. THE CONTRAST TO SALINE RATIO WAS 1:1. THE BALLOON RE-WRAPPED PROPERLY. THE BALLOON WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE DURING THE PROCEDURE. THERE WAS NO FRICTION FELT DURING THE DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 15330642

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention