BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS+ V 45 CM M0.7 G-2

    MDR report key: 13203424 · Received January 10, 2022

    Report

    Report Number
    2210968-2022-00189
    Event Type
    Injury
    Date Received
    January 10, 2022
    Report Date
    January 10, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. NO. PATIENT DEMOGRAPHICS? A 2.2-KG TERM MALE NEONATE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 1/10/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ¿ TRADE NAME - IRGACARE®. ¿ ACTIVE INGREDIENT(S) ¿ TRICLOSAN. ¿ DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. ¿ STRENGTH ¿ : 2360 G/M.

    Description of Event or Problem · 0

    SUCCESSFUL THORACOSCOPIC TREATMENT FOR TRACHEOESOPHAGEAL FISTULA AND ESOPHAGEAL ATRESIA OF COMMUNICATING BRONCHOPULMONARY FOREGUT MALFORMATION GROUP IB WITH DEXTROCARDIA: A CASE REPORT OF VACTERL ASSOCIATION. BACKGROUND: A COMMUNICATING BRONCHOPULMONARY FOREGUT MALFORMATION (CBPFM) GROUP IB IS VERY RARE CONGENITAL MALFORMATION. GROUP IB IS ASSOCIATED WITH TRACHEOESOPHAGEAL FISTULA AND ESOPHAGEAL ATRESIA (TEF-EA) AND A PORTION OF ONE LUNG ARISEN FROM THE ESOPHAGUS (GERLE ET AL. IN N ENGL J MED. 278:1413-1419, 1968). THE COEXISTENCE OF TEF-EA AND DEXTROCARDIA IS ALSO A RARE AND CHALLENGING SETTING FOR REPAIR OF TEF-EA. THEREFORE, THE THORACOSCOPIC SURGERY FOR TEF-EA REQUIRE THE TECHNICAL DEVISE BECAUSE OF THE SMALL OPERATIVE SPACE. WE HEREIN REPORT A RARE CASE OF CBPFM GROUP IB WITH INTRALOBAR SEQUESTRATION OF LUNG AND A SUCCESSFUL PERFORMING OF THORACOSCOPIC SURGERY FOR EA WITH DEXTROCARDIA IN VACTERL ASSOCIATION. CASE PRESENTATION: A 2.2-KG TERM MALE NEONATE WAS BORN WITH AN ANAL ATRESIA, COARCTATION OF THE AORTA, TEF-EA, RENAL ANOMALIES, RADIAL HEMIMELIA, LIMB ABNORMALITIES (VACTERL ASSOCIATION) AND HYPOPLASIA OF THE RIGHT LUNG WITH DEXTROCARDIA. THE PATIENT DEVELOPED RESPIRATORY DISTRESS AFTER ADMISSION. A TWO-STAGE OPERATION FOR THE TEF-EA WAS PLANNED BECAUSE OF MULTIPLE ANOMALIES AND CARDIAC CONDITION. IN THE NEONATAL PERIOD, ESOPHAGEAL BANDING AT THE GASTROESOPHAGEAL JUNCTION AND GASTROSTOMY WERE PERFORMED TO ESTABLISH ENTERAL NUTRITION. AFTER GAINING BODY WEIGHT AND ACHIEVING A STABLE CARDIAC CONDITION, THORACOSCOPIC SURGERY FOR TEF-EA WAS PERFORMED. THE THORACOSCOPIC FINDINGS REVEALED A SMALL WORKING SPACE DUE TO DEXTROCARDIA. TO OBTAIN A SUFFICIENT WORKING SPACE AND TO PERFORM SECURE ESOPHAGEAL ANASTOMOSIS, AN ADDITIONAL 3-MM ASSISTANT PORT WAS INSERTED. TO CLOSE THE UPPER AND LOWER ESOPHAGUS, ANCHORING SUTURES OF THE ESOPHAGUS WERE PLACED AND WERE PULLED TO SUSPEND THE ANASTOMOTIC SITE. ESOPHAGEAL ANASTOMOSIS WAS SUCCESSFULLY PERFORMED. AN ESOPHAGOGRAM AFTER TEF-EA SURGERY SHOWED THE CONNECTION BETWEEN THE LOWER ESOPHAGUS AND RIGHT LOWER LUNG. THE DEFINITIVE DIAGNOSIS WAS CBPFM GROUP IB WITH INTRALOBAR SEQUESTRATION. THE THORACOSCOPIC SURGERY WAS PERFORMED AGAIN FOR ESTABLISHING ORAL INTAKE. AFTER TRANSECTION OF THE BRONCHOESOPHAGEAL FISTULA, THE PATIENT COULD PERFORM ORAL FEEDING WITHOUT PNEUMONIA OR RESPIRATORY DISTRESS. CONCLUSIONS: CBPFM TYPE IB WITH INTRALOBAR SEQUESTRATION IS A RARE CONDITION. CBPFM TYPE IB SHOULD BE CONSIDERED FOR A PATIENTS WITH RESPIRATORY SYMPTOM AFTER RADICAL OPERATION FOR TEF-EA. IN THE PRESENT CASE, SUSPENDING THE ANASTOMOTIC SITE WAS EFFECTIVE AND USEFUL IN THORACOSCOPIC SURGERY FOR A TEF-EA PATIENT WITH DEXTROCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476008 PDS+ V 45 CM M0.7 G-2 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention