BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2202038 · Received August 5, 2011

    Report

    Report Number
    2024601-2011-00618
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN EXPLANTED AND RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF EXPLANTED. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. OBSTRUCTION, BAND SLIPPAGE, VOMITING, AND ADHESIONS (SCARRING) ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: "OBSTRUCTION OF STOMAS HAS BEEN REPORTED AS BOTH AN EARLY AND A LATE COMPLICATION OF THIS PROCEDURE. THIS CAN BE CAUSED BY EDEMA, FOOD, IMPROPER INITIAL CALIBRATION, BAND SLIPPAGE, POUCH TORSION, OR PATIENT NONCOMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD. VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AS FOLLOWS: "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION. THE DISSECTION SHOULD BE THE SAME SIZE AS THE BAND OR EVEN SMALLER TO REDUCE THE POSSIBILITY OF BAND AND/OR STOMACH SLIPPAGE." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ADHESIONS AS FOLLOWS: "GASTRIC BANDING DONE AS A REVISION PROCEDURE HAS A GREATER RISK OF COMPLICATIONS. PRIOR ABDOMINAL SURGERY IS COMMONLY ASSOCIATED WITH ADHESIONS INVOLVING THE STOMACH. IN THE (B)(4) STUDY OF SEVERELY OBESE ADULTS, 42% OF THE SUBJECTS UNDERGOING REVISION SURGERY WERE REPORTED TO HAVE ADHESIONS INVOLVING THE STOMACH. CARE AND TIME MUST BE TAKEN TO ADEQUATELY RELEASE THE ADHESIONS TO PROVIDE ACCESS, EXPOSURE AND MOBILIZATION OF THE STOMACH FOR A REVISION PROCEDURE."

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING A YEAR AFTER IMPLANT ALLEGEDLY "TOO MUCH RESTRICTION WITH VOMITING" WITH A LAP-BAND DEVICE. THE PATIENT STATED THE SURGEON PERFORMED "AN X-RAY", WHICH DIDN'T' DETERMINE THE CAUSE. THE SURGEON SUCCESSFULLY COMPLETED SURGERY TO REMOVE SCAR TISSUE AND THAT THE "BAND DIDN'T' HOLD UP TO ADHESION AND THE BAND BUCKLED." AT A LATER DATE THE PATIENT EXPERIENCED TOO MUCH RESTRICTION WITH VOMITING AGAIN. SURGERY HAS BEEN SCHEDULED, BUT WHAT EXACTLY WILL BE DONE IS UNCERTAIN. FOLLOW-UP FINDINGS: A HEALTH PROFESSIONAL AT THE SURGEON'S OFFICE STATED THAT THE PATIENT "DID HAVE ABDOMINAL ADHESIONS." WHILE REMOVING THE ADHESIONS, THE DOCTOR FOUND THAT HER PORT FLIPPED BECAUSE OF THE ABDOMINAL ADHESIONS, SO THE SURGEON ALSO "FIXED THE PORT" BY REATTACHING IT TO THE ABDOMINAL WALL. THE PATIENT IS COMING INTO THE OFFICE AT A LATER DATE "FOR AN UPPER GI", AS THE PATIENT MIGHT ALSO HAVE AN ESOPHAGEAL DILATATION. FOLLOW UP FINDINGS: THE UPCOMING APPOINTMENT WITH THE SURGEON IS NOT A SURGERY BUT THE DOCTOR MAY WANT TO PUT A BALLOON INTO THE ESOPHAGUS AND STOMACH TO WIDEN THE PASSAGE/ TISSUE, CALLED A GASTRIC DILATION. AN "UPPER GI" WILL BE DONE. THE SURGEON "WILL BE GOING IN THROUGH THE ESOPHAGUS AND WILL LOOK AROUND TO SEE WHAT NEEDS TO BE DONE." THE DEVICE IS NOT BEING EXPLANTED AT THIS TIME. DURING PREVIOUS SURGERY DONE TO TAKE OUT THE ADHESIONS THE PATIENT HAD AROUND HER STOMACH, THE SURGEON NOTED A "DOWNWARD DISPLACEMENT OR TORKING ON BAND DUE TO THE ADHESIONS, CAUSING KINKING OF STOMACH AND OBSTRUCTION OF STOMACH." THE SURGEON TOOK OUT THE ADHESIONS IN ORDER TO FREE THE BAND AND STOMACH. THE HEALTH PROFESSIONAL REPORTED THAT THERE IS ACTUALLY NO ESOPHAGEAL DILATATION AND NO PORT DISPLACEMENT AFTER ALL. FOLLOW UP FINDINGS: DURING THE APPOINTMENT WITH THE PATIENT THE SURGEON PUT "CONTRAST INTO THE BAND AND IT FLOWED FREELY TO THE BAND." THE SURGEON THOUGHT THERE "MIGHT BE AN ESOPHAGEAL MOBILITY ISSUE" AND ASKED THE PATIENT IF THE PATIENT HAD THAT BEFORE TO WHICH THE PATIENT ANSWERED NO. THE SURGEON ALSO PERFORMED AN "EGD" AND ANOTHER "SWALLOW STUDY" AND NOTICED THAT THERE WEREN'T ANY "RESTRICTION PROBLEMS" AND THAT "EVERYTHING LOOKED NORMAL." THERE WAS "NO OBSTRUCTION" OR KINKING TO THE ESOPHAGUS, STOMACH, OR THE BAND. THE SURGEON STATED HAVING CONFUSION AS TO WHY THE PATIENT IS STILL HAVING TROUBLE AND "CAN'T TOLERATE SOLIDS." THE DEVICE REMAINS IMPLANTED AT THIS TIME. ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1710504

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention NONE REPORTED.