BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7654531 · Received July 2, 2018

    Report

    Report Number
    3001845648-2018-00307
    Event Type
    Injury
    Date Received
    July 2, 2018
    Report Date
    June 4, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510 K #: K163468. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THE EVO-XX-XX-XX-D STENT OF UNKNOWN LOT NUMBER WAS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED IN THE COMPLAINT FILE: 1.DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. 2.DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. 4. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 5. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. ITEM 1 THE DR STATED IN THE ORIGINAL REPORT: ¿PERFORATION OCCURRED WITHIN 24 HOURS OF ORIGINAL PROCEDURE, MAY HAVE BEEN DUE TO PATIENT MOVEMENT." FINAL ANSWER: PATIENT DIDN¿T MOVE (MUST HAVE BEEN MISINTERPRETED BY CUSTOMER RELATIONS WHEN PHONE CALL CAME THROUGH). DM MAY HAVE BEEN REFERRING TO FORESHORTENING (TYPICAL) OF STENT. PATIENT HAD WEAK TISSUE. ITEM 2 THE RESPONSE INDICATED THAT THE PERFORATION WAS DETECTED DURING ABDOMINAL SURGERY. WHAT WAS THE PURPOSE OF THIS SURGERY? FINAL ANSWER: PATIENT HAS ADVANCED PANCREATIC CANCER, THIS WEAKENING INVOLVED THE PATIENT¿S DUODENUM COLLAPSING. ITEM 3 ¿Q. WAS THE PERFORATION LIFE-THREATENING? HE HAD CANCER....?¿ CAN THE DOCTORS PLEASE CLARIFY IF THE PERFORATION ITSELF WAS POTENTIALLY LIFE-THREATENING? FINAL ANSWER: STENT PERFORATION IS A PERIPHERAL ISSUE, THE CANCER ITSELF IS LIFE-THREATENING ITEM 4 ¿Q. DID THE PATIENT EXPERIENCE ANY PERMANENT IMPAIRMENT/INJURY AS A RESULT OF THE PERFORATION? YES TPN 3 MONTHS¿ FINAL ANSWER: CORRECTION TO ORIGINAL ANSWER; AS TPN WAS 3 MONTHS, IT WAS NOT PERMANENT. NO OTHER PERMANENT IMPAIRMENTS OR INJURIES AS A RESULT OF THE PERFORATION ¿WERE THERE ANY DIFFICULTIES DURING THE INITIAL PROCEDURE? NO ¿WAS THE STENT POSITION CONFIRMED DURING AND AFTER PLACEMENT? YES ¿WHAT SORT/DEGREE OF PATIENT MOVEMENT OCCURRED FOLLOWING THE INITIAL PROCEDURE? NONE ¿WHERE WAS THE PERFORATION LOCATED AND HOW WAS IT DETECTED? DUODENUM/ SURGERY OF ABDOMEN ¿WAS THE PERFORATION LIFE-THREATENING? HE HAD CANCER....? ¿HOW WAS THE PERFORATION TREATED? HOSPITALIZATION TPN 3 MONTHS ¿WHAT ADVERSE EFFECTS DID THE PATIENT EXPERIENCE AS A RESULT, WHAT LED TO THEIR PROLONGED HOSPITALIZATION? TORE AT D 1 JUNCTION ABSCESS INVOLVES ¿DID THE PATIENT EXPERIENCE ANY PERMANENT IMPAIRMENT/INJURY AS A RESULT OF THE PERFORATION? YES TPN 3 MONTHS _______________________________ 1.1 FOR ALL COMPLAINTS, ASK: 1.1.1 WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? BOSTON SCIETIFIC JAGWIRE 1.1.2 IF NOT, WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? N/A (ISSUE OCCURRED AFTER PROCEDURE COMPLETED) 1.2 FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH PATIENT) ALSO ASK: 1.2.1 WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? OLYMPUS 1.2.2 HAD DILATION OF THE STRICTURE BEEN PERFORMED PRIOR TO STENT PLACEMENT? NO 1.2.3 WHAT WAS THE DIAMETER OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN MM)? 8MM 1.2.4 WHAT WAS THE LENGTH OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN CM)? SHORT 1.2.5 PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. DUODENUM 1.2.6 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE STRICTURE? NO 1.2.7 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCER AND STENT INTO POSITION? YES 1.2.8 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. 1.2.9 WAS THE STENT PARTIALLY DEPLOYED WHEN REMOVED FROM THE PATIENT? N/A 1.2.10 AFTER PLACEMENT, WAS STENT POSITION VERIFIED? 1.2.10.1 IF YES, PLEASE DESCRIBE HOW. 1.2.11 AFTER PLACEMENT, WAS THE ENDOSCOPE ADVANCED THROUGH THE STENT? YES PROXIMAL END 1.2.12 PLEASE ESTIMATE AMOUNT OF TIME THE STENT WAS IN PLACE PRIOR TO THIS OCCURRENCE. 24 HOURS 1.2.13 DID THE PATIENT UNDERGO CHEMOTHERAPY OR RADIATION TREATMENTS AFTER STENT PLACEMENT? NO THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ROOT CAUSE: THERE WAS NO DEVICE RETURNED FOR INVESTIGATION, AND NO IMAGES AVAILABLE FOR REVIEW THEREFORE A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, AS PER THE INSTRUCTIONS FOR USE,STENT MIGRATION AND INTESTINAL PERFORATION IS LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. DOCUMENT REVIEW: THE EVO-XX-XX-XX-D STENT OF LOT NUMBER UNKNOWN COULD NOT BE DOCUMENT REVIEWED DUE TO LACK OF PRODUCT INFORMATION PRIOR TO DISTRIBUTION ALL EVOLUTION STENTS - NON-BILIARY, DUODENAL METAL DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. ¿INSPECT FOR VISUAL DEFECTS; I.E. LOOSE OR EMBEDDED FOREIGN MATERIALS, KINKS, ROUGH OR SHARP EDGES.¿ ¿VISUAL INSPECTIONS OF PRODUCT AND PACKAGING¿ THE RELEVANT MTM IS INSTRUCTED TO CHECK FOR ¿VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS.¿ SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORTING UNDER "SERIOUS INJURY" AND THE PRECEDENCE OF "STENT NOT EXPANDING/OPENING POST-DEPLOYMENT". AS REPORTED TO CUSTOMER RELATIONS: "PHYSICIAN PLACED STENT THAT PERFORATED THE PATIENT, PATIENT WAS ADMITTED FOR 126 DAYS AFTERWARDS. PERFORATION OCCURRED WITHIN 24 HOURS OF ORIGINAL PROCEDURE, MAY HAVE BEEN DUE TO PATIENT MOVEMENT." ADDITIONAL INFORMATION PROVIDED BY DM ON 06JUN2018: "HE ALSO SAID THE PATIENT HAD ADVANCED PANCREATIC CANCER AND THE TISSUE ITSELF WASN¿T NORMAL TISSUE. THE SURGEON SAID THAT THE STENT WAS VISIBLE ON BOTH SIDES." ADDITIONAL INFORMATION PROVIDED BY DM ON 07JUN2018: "PER PHYSICIAN, PATIENT DIDN¿T MOVE (MUST HAVE BEEN MISINTERPRETED BY CUSTOMER RELATIONS WHEN PHONE CALL CAME THROUGH). DM MAY HAVE BEEN REFERRING TO FORESHORTENING (TYPICAL) OF STENT. PATIENT HAD WEAK TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498265 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization