BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAN 2 LITE LAYER COMPRESSION SYSTEM

    MDR report key: 7107289 · Received December 11, 2017

    Report

    Report Number
    2110898-2017-00149
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    June 5, 2017
    Report Date
    March 27, 2018
    Manufacturer
    3M HEALTH CARE
    Product Code
    FQM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PULMONARY EMBOLISM OCCURS AT A KNOWN RATE POSTOPERATIVELY FOLLOWING JOINT REPLACEMENT SURGERY. WHEN THE REPORT WAS RECEIVED ON (B)(6) 2017, THERE WAS NO EVIDENCE TO SUGGEST THAT THE OCCURRENCE OF THE PULMONARY EMBOLISM WAS RELATED TO THE USE OF 3M COBAN 2 LITE LAYER COMPRESSION SYSTEM POST TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2017 3M RECEIVED THE 4TH REPORT OF A PULMONARY EMBOLISM IN THIS STUDY. 3M CONTACTED THE STUDY INVESTIGATORS TO OBTAIN ADDITIONAL PATIENT DETAILS REGARDING OPERATIVE DURATION, PATIENT COMORBIDITIES AND MEDICAL HISTORY. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH THERE WAS STILL NO EVIDENCE TO SUGGEST THAT THE OCCURRENCE OF PULMONARY EMBOLISM WAS RELATED TO THE USE OF 3M COBAN 2 LITE LAYER COMPRESSION SYSTEM POST TOTAL KNEE ARTHROPLASTY, ON (B) (6)2017 3M MADE THE DECISION TO SEND MDR REPORTS FOR ALL FOUR CASES. 2110898-2017-000146 WAS SENT FOR REPORT RECEIVED ON (B)(4) 2017. ON (B)(4) 2017 MDR REPORT NUMBERS 2110898-2017-00148, 2110898-2017-00149 AND 2110898-2017-00150 WERE SENT BASED ON TREND ANALYSIS. H6 CONCLUSION CODE 20 (INCONCLUSIVE- INVESTIGATION IN PROGRESS) WAS USED. THERE WAS NO CONCLUSIVE EVIDENCE THAT THE OCCURRENCE OF A PULMONARY EMBOLISM WAS RELATED TO THE USE OF 3M COBAN 2 LITE LAYER COMPRESSION SYSTEM POST TOTAL KNEE ARTHROPLASTY. 3M WILL CONTINUE TO MONITOR COMPLAINTS AND TRENDS FOR THIS TYPE OF REPORT.

    Additional Manufacturer Narrative · 1

    3M RECEIVED A FORMAL LETTER FROM THE (B)(6) REGARDING THEIR INVESTIGATION OF THE FOUR PULMONARY EMBOLISMS THAT OCCURRED WITHIN THE INVESTIGATOR-INITIATED RESEARCH STUDY ENTITLED "THE USE OF 3M¿ COBAN¿ 2 LITE LAYER COMPRESSION SYSTEM POST-TOTAL KNEE ARTHROPLASTY". THE (B)(6) CONSULTED WITH TWO INDEPENDENT CONTENT EXPERTS TO INVESTIGATE THE ETIOLOGY OF THE PULMONARY EMBOLISMS AND TO DETERMINE WHETHER THEY WERE RELATED TO THE STUDY INTERVENTION, I.E., THE 3M¿ COBAN¿ 2 LITE LAYER COMPRESSION SYSTEM. IN BRIEF, THE INDEPENDENT CONTENT EXPERTS REACHED CONSENSUS THAT THE FOUR PES WERE LIKELY UNRELATED TO THE STUDY INTERVENTION 3M¿ COBAN¿ 2 LITE LAYER COMPRESSION SYSTEM. - [3M COBAN STUDY_PE INVESTIGATION LETTER_MAR 21 2018.PDF].

    Description of Event or Problem · 1

    AN INDEPENDENT STUDY INVESTIGATOR REPORTED COBAN 2 LITE LAYER COMPRESSION SYSTEM WAS APPLIED TO A (B)(6) FEMALE PATIENT FOLLOWING A TOTAL KNEE ARTHROPLASTY. A RESEARCH TEAM MEMBER REPORTEDLY DISCOVERED THE PATIENT EXPERIENCED A PULMONARY EMBOLISM ON POST OP DAY FOUR WHEN THEY WERE COMPLETING THE TWO WEEK FOLLOW-UP PHONE INTERVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882633 COBAN 2 LITE LAYER COMPRESSION SYSTEM COBAN 2 LITE LAYER COMPRESSION SYSTEM FQM 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other