UNKNOWN ENDO GIA SULU
Report
- Report Number
- 1219930-2022-02813
- Event Type
- Injury
- Date Received
- July 22, 2022
- Date of Event
- August 16, 2021
- Report Date
- July 22, 2022
- Manufacturer
- COVIDIEN LP LLC NORTH HAVEN
- Product Code
- GDW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
TITLE: COMPARISON OF MID-TERM EFFECTIVENESS AND SAFETY OF ONE-ANASTOMOSIS GASTRIC BYPASS AND SLEEVE GASTRECTOMY IN PATIENTS WITH SUPER OBESITY (BMI=50 KG/M2) SOURCE: SURGERY TODAY (2022) 52:854¿862 HTTPS://DOI.ORG/10.1007/S00595-021-02387-2. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MARCH 2013 AND 2017, RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF ONE-ANASTOMOSIS GASTRIC BYPASS (OAGB) WITH THOSE OF SLEEVE GASTRECTOMY IN PATIENTS WITH SUPER OBESITY. THREE HUNDRED FORTY EIGHT (348) PATIENTS UNDERWENT SLEEVE GASTRECTOMY (SG) WHEREIN 75¿80% OF THE BODY AND FUNDUS IS EXCISED. THE GASTRIC TUBE IS CREATED OVER A 36-F BOUGIE USING MULTIPLE FIRINGS OF A STAPLER. TWO HUNDRED NINE (209) PATIENTS UNDERWENT OAGB WHEREIN A LONG GASTRIC TUBE WAS CREATED USING THE DEVICE FROM THE INCISURA ANGULARIS TO THE ANGLE OF HIS OVER A 36-F BOUGIE. AN ANTECOLIC LOOP GASTROJEJUNOSTOMY WAS PERFORMED 160 OR 200 CM DISTAL TO THE LIGAMENT OF TRIETZ WITH THE DEVICE AND REINFORCED WITH CONTINUOUS SUTURES. POST OPERATIVE COMPLICATIONS WERE ONE PATIENT BLEEDING FROM OAGB GROUP. BLOOD TRANSFUSION DUE TO BLEEDING WERE REQUIRED ON SIX (6) PATIENTS FROM SG WHILE THERE WERE A TOTAL FOURTEEN (14) PATIENTS FROM OAGB. THREE (3) PATIENTS FROM SG AND 6 PATIENTS FROM OAGB HAD REOPERATIONS. READMISSION WERE REPORTED IN A TOTAL TWENTY SIX (26) PATIENTS FROM OAGB AND TWELVE IN SG GROUP. ONE PATIENT IN SG GROUP HAD LEAKAGE OR ABSCESS. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED: PULMONARY EMBOLISM, INFECTION, DEEP VEIN THROMBOSIS, PROTEIN¿CALORIE MALNUTRITION, VOMITING, REFLUX, MARGINAL ULCER AND INTESTINAL OBSTRUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560976 | UNKNOWN ENDO GIA SULU | STAPLE, IMPLANTABLE | GDW | COVIDIEN LP LLC NORTH HAVEN | UNKNOWN ENDO GIA SULU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other| R |