BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 2221376 · Received August 24, 2011

    Report

    Report Number
    9616099-2011-00664
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00661 AND 9616099-2011-00662. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Description of Event or Problem · 1

    AT PRE-PROCEDURE ON (B)(6) 2010, THE ABI WAS 0.55 ON THE RIGHT AND 0.47 ON THE LEFT. ON (B)(6) 2010, THE PATIENT PARTICIPATED IN THE (B)(4) STUDY AND SHE WAS ALLOCATED TO THE POBA GROUP. A SLEEK BALLOON AND A POWERFLEX BALLOON WERE USED. HOWEVER, IT BECAME A BAILOUT BECAUSE OF A DISSECTION (AFTER USE OF THE POWERFLEX), AND BAILOUT STENTING WAS PERFORMED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, STUDY DEVICES WERE PLACED (DIAMETER 7 MM X LENGTH 80 MM, DIAMETER 7 MM X LENGTH 100 MM). ON (B)(6) 2010, SHE WAS DISCHARGED. AT THE 30-DAY FOLLOW-UP VISIT ON (B)(6) 2011, THE ABI WAS 0.85 ON THE RIGHT AND 0.51 ON THE LEFT. ON (B)(6) 2011, THE ABI WAS 0.82 ON THE RIGHT AND 0.51 ON THE LEFT. ON (B)(6) 2011, THE ABI WAS 0.57 ON THE RIGHT AND 0.55 ON THE LEFT. ON (B)(6) 2011, SHE WAS ADMITTED FOR TREATMENT OF THE LEFT SUPERFICIAL FEMORAL ARTERY OCCLUSION. ON (B)(6) 2011, THREE STENTS WERE PLACED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (DIAMETER 7 MM X LENGTH 40 MM X1, DIAMETER 6 MM X 100 MM X 2). NO RESIDUAL STENOSIS WAS NOTED. ON (B)(6) 2011, THE RIGHT ABI WAS UNMEASURABLE BECAUSE OF PULSE OF SMALL AMPLITUDE. THE LEFT ABI WAS 0.89. AFTER THE TREATMENT OF LEFT SUPERFICIAL FEMORAL ARTERY, SHE WAS DOING WELL AND CONSIDERED RECOVERED WITHOUT SEQUELAE. ON (B)(6) 2011, THE ECHO WAS PERFORMED ON THE RIGHT LOWER EXTREMITY. IT REVEALED THE IN-STENT RESTENOSIS OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AND ALSO SUSPECTED THE STENOSIS OR OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY. HOSPITALIZATION WAS EXTENDED FOR THE PERCUTANEOUS TRANSMITTAL INTERVENTION WHICH WAS SCHEDULED ON (B)(6) 2011. ON (B)(6) 2011, A STENT WAS PLACED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (DIAMETER 8 MM X LENGTH 30 MM). ON (B)(6) 2011, THE RIGHT LOWER EXTREMITY PAIN HAD BEEN CONTINUED. THE ECHO REVEALED THE STENOSIS OF THE RIGHT COMMON FEMORAL ARTERY. SHE WAS EXTENDED HOSPITALIZATION FOR THE PERCUTANEOUS TRANSMITTAL INTERVENTION. ON (B)(6) 2011, A STENT WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY (10 X 40MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SLEEK BALLOON