BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 12237017 · Received July 28, 2021

    Report

    Report Number
    9616099-2021-04736
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    June 3, 1993
    Report Date
    July 28, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: SAEED, M., KNOWLES, H. J., JR, BREMS, J. J., & TAKIFF, H. (1993). PERCUTANEOUS RETRIEVAL OF A LARGE PALMAZ STENT FROM THE PULMONARY ARTERY. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 4(6), 811¿814. HTTPS://DOI.ORG/10.1016/S1051-0443(93)71979. SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: 20-MM ANGIOPLASTY BALLOON (MEDI-TECH/BOSTON SCIENTIFIC, AMPLATZ GOOSE NECK 5-MM SNARE (MICROVENA, VADNAIS HEIGHTS, MINN 24-F COONS-AMPLATZ SHEATH (MEDI-TECHI BOSTON SCIENTIFIC), 25 -MM GOOSE NECK SNARE. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE BY SAEED, M., KNOWLES, H. J., JR, BREMS, J. J., & TAKIFF, H. (1993). PERCUTANEOUS RETRIEVAL OF A LARGE PALMAZ STENT FROM THE PULMONARY ARTERY. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 4(6), 811¿814. HTTPS://DOI.ORG/10.1016/S1051-0443(93)71979- A GUIDE WIRE WAS SELECTIVELY ADVANCED INTO THE LEFT PULMONARY ARTERY FROM THE RIGHT FEMORAL APPROACH, AND A NON-CORDIS DEVICE 20-MM ANGIOPLASTY BALLOON WAS ADVANCED OVER IT AND INTO THE EMBOLIZED STENT. WITH INFLATION OF THE BALLOON, THE STENT WAS ENGAGED, AND THE BALLOON WAS THEN CAREFULLY RETRACTED INTO THE RIGHT ATRIUM AND THEN ADVANCED TO THE SUPERIOR VENA CAVA. NO SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING PASSAGE OF THE STENT THROUGH THE CARDIAC CHAMBERS. THE WIRE THROUGH THE BALLOON CATHETER WAS THEN TRAPPED IN A NON-CORDIS 5-MM SNARE FROM THE RIGHT JUGULAR VENOUS APPROACH AND WAS BROUGHT OUT THROUGH THE JUGULAR VENOUS SHEATH. THE RIGHT JUGULAR VENOUS TRACT WAS THEN DILATED, AND A NON-CORDIS 24-F SHEATH WAS INTRODUCED. A 25-MM NON-CORDIS SNARE WAS THEN INTRODUCED THROUGH A TORQUE-CONTROL BRAIDED CATHETER OVER THE GUIDE WIRE AND WAS ADVANCED INTO THE SUPERIOR VENA CAVA TO ENCIRCLE THE BALLOON-MOUNTED STENT. DURING THIS MANEUVER, THE GUIDE WIRE WAS FIXED AT BOTH THE FEMORAL AND JUGULAR ENDS. WITH THE SNARE SECURELY AROUND THE STENT, THE BALLOON WAS ADVANCED TO THE TIP OF THE NON-CORDIS SHEATH, AND, WITH SIMULTANEOUS TIGHTENING OF THE SNARE AND DEFLATION OF THE BALLOON, THE STENT WAS COMPRESSED AROUND THE DEFLATING BALLOON TO ALLOW ADVANCEMENT OF THE BALLOON AND STENT INTO THE NON -CORDIS SHEATH. ONCE INSIDE THE SHEATH, THE BALLOON AND STENT WERE RAPIDLY EXTRUDED THROUGH THE BACK OF THE SHEATH AND THE STENT WAS REMOVED BY AMPUTATING THE BALLOON FROM ITS SHAFT. THE BALLOON CATHETER WAS THEN RETRACTED AND SUBSEQUENTLY REMOVED FROM THE FEMORAL APPROACH. THE NON-CORDIS SHEATH WAS REMOVED, AND HEMOSTASIS WAS OBTAINED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿STENT MIGRATION¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS OR PROCEDURAL FACTORS, SUCH AS AN UNDEREXPANDED STENT, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF TRANSHEPATIC BILIARY ENDOPROSTHESES MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: STENT MIGRATION. MEASURE THE DIAMETER OF THE REFERENCE DUCT TO DETERMINE THE APPROPRIATE SIZE STENT AND DELIVERY SYSTEM. USING AN INFLATION DEVICE, STEADILY INFLATE THE BALLOON UNDER FLUOROSCOPY TO THE NOMINAL PRESSURE RECOMMENDED ON THE CATHETER LABEL. EXPAND THE DIAMETER OF THE STENT TO THE DIAMETER OF THE REFERENCE BILE DUCT.¿ NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY SAEED, M., KNOWLES, H. J., JR, BREMS, J. J., & TAKIFF, H. (1993). PERCUTANEOUS RETRIEVAL OF A LARGE PALMAZ STENT FROM THE PULMONARY ARTERY. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 4(6), 811¿814. HTTPS://DOI.ORG/10.1016/S1051-0443(93)71979- A GUIDE WIRE WAS SELECTIVELY ADVANCED INTO THE LEFT PULMONARY ARTERY FROM THE RIGHT FEMORAL APPROACH, AND A NON-CORDIS DEVICE 20-MM ANGIOPLASTY BALLOON WAS ADVANCED OVER IT AND INTO THE EMBOLIZED STENT. WITH INFLATION OF THE BALLOON, THE STENT WAS ENGAGED, AND THE BALLOON WAS THEN CAREFULLY RETRACTED INTO THE RIGHT ATRIUM AND THEN ADVANCED TO THE SUPERIOR VENA CAVA. NO SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING PASSAGE OF THE STENT THROUGH THE CARDIAC CHAMBERS. THE WIRE THROUGH THE BALLOON CATHETER WAS THEN TRAPPED IN A NON-CORDIS 5-MM SNARE FROM THE RIGHT JUGULAR VENOUS APPROACH AND WAS BROUGHT OUT THROUGH THE JUGULAR VENOUS SHEATH. THE RIGHT JUGULAR VENOUS TRACT WAS THEN DILATED, AND A NON-CORDIS 24-F SHEATH WAS INTRODUCED. A 25-MM NON-CORDIS SNARE WAS THEN INTRODUCED THROUGH A TORQUE-CONTROL BRAIDED CATHETER OVER THE GUIDE WIRE AND WAS ADVANCED INTO THE SUPERIOR VENA CAVA TO ENCIRCLE THE BALLOON-MOUNTED STENT. DURING THIS MANEUVER, THE GUIDE WIRE WAS FIXED AT BOTH THE FEMORAL AND JUGULAR ENDS. WITH THE SNARE SECURELY AROUND THE STENT, THE BALLOON WAS ADVANCED TO THE TIP OF THE NON-CORDIS SHEATH, AND, WITH SIMULTANEOUS TIGHTENING OF THE SNARE AND DEFLATION OF THE BALLOON, THE STENT WAS COMPRESSED AROUND THE DEFLATING BALLOON TO ALLOW ADVANCEMENT OF THE BALLOON AND STENT INTO THE NON -CORDIS SHEATH. ONCE INSIDE THE SHEATH, THE BALLOON AND STENT WERE RAPIDLY EXTRUDED THROUGH THE BACK OF THE SHEATH AND THE STENT WAS REMOVED BY AMPUTATING THE BALLOON FROM ITS SHAFT. THE BALLOON CATHETER WAS THEN RETRACTED AND SUBSEQUENTLY REMOVED FROM THE FEMORAL APPROACH. THE NON-CORDIS SHEATH WAS REMOVED, AND HEMOSTASIS WAS OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132973 UNKNOWN PALMAZ STENT CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION PXXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R