ECHELON ENDOPATH STAPLER
Report
- Report Number
- 3005075853-2022-07432
- Event Type
- Death
- Date Received
- October 31, 2022
- Date of Event
- March 26, 2022
- Report Date
- October 31, 2022
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
(B)(4). PUBLICATION DATE 2022, EXACT EVENT DATE UNK. BATCH # UNK. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE?. IF YES, PLEASE EXPLAIN. WOULD THE SURGEON BE INTERESTED IN SPEAKING WITH ETHICON MEDICAL AND ENGINEERING PERSONNEL?. PLEASE PROVIDE 3 THIRTY-MINUTE WINDOWS OF TIME (EASTERN US TIME) THE SURGEON IS AVAILABLE, AND OUR TEAM WILL CHOOSE THE ONE THAT THE MOST TEAM MEMBER CAN PARTICIPATE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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.
TITLE: COMPUTED TOMOGRAPHY ASSESSMENT OF POSTOPERATIVE GASTRIC VASCULAR SUPPLY AND STAPLE-LINE LEAK DEVELOPMENT AFTER SLEEVE GASTRECTOMY. AUTHOR: HADRIEN TRANCHART, FLORENCE LLOUQUET, JOSEPH DERIENNE, MARTIN GAILLARD, GEORGE RAFEK, ANTOINE GRASSIN, COSMIN SEBASTIAN VOICAN, GIANFRANCO DONATELLI, LAURENCE ROCHER, IBRAHIM DAGHER. CITATION: SURGERY FOR OBESITY AND RELATED DISEASES 18 (2022) 812¿819, HTTPS://DOI.ORG/10.1016/J.SOARD.2022.03.018. THE AIM OF THE STUDY IS TO COMPARE THE POSTOPERATIVE VASCULARIZATION OF THE GASTRIC TUBE USING EARLY COMPUTED TOMOGRAPHY (CT) SCANNING AFTER SG IN PATIENTS WITH OR WITHOUT POSTOPERATIVE STAPLE-LINE LEAK. A RETROSPECTIVE ANALYSIS OF A PROSPECTIVE DATABASE WAS PERFORMED IN CONSECUTIVE PATIENTS UNDERGOING SG. PATIENTS WHO PRESENTED WITH A STAPLE-LINE LEAK WERE MATCHED (1:3) WITH A CONTROL GROUP OF PATIENTS WHO UNDERWENT SURGERY WITHOUT POSTOPERATIVE MORBIDITY DURING THE SAME PERIOD. GASTRIC TUBE VASCULARIZATION WAS STUDIED ON A POSTOPERATIVE DAY 2 CT SCAN IN BOTH GROUPS OF PATIENTS. 1826 PATIENTS UNDERWENT SG, INCLUDING 42 PATIENTS (2.3%) WHO PRESENTED WITH A STAPLE-LINE LEAK. THOSE 42 PATIENTS WERE SUCCESSFULLY MATCHED TO 126 CONTROL PATIENTS. ECHELON FLEX POWERED WITH A GOLD CARTRIDGE [3.8 MM; ETHICON ]WAS USED. REPORTED COMPLICATIONS INCLUDED GASTRIC LEAK DUE TO AN INABILITY TO CONTROL BLEEDING FROM A SHORT GASTRIC VESSEL (N=1), GASTRIC LEAK (N=23) , DEATH DUE TO SEPTIC SHOCK (N=1), CLAVIEN DINDO GRADE IIIB, CLAVIEN DINDO GRADE IVA, CLAVIEN DINDO GRADE IVB. IN CONCLUSION THIS STUDY SUGGESTS A CORRELATION BETWEEN INTERRUPTION OF THE MAIN ARTERIES SUPPLYING THE GASTROESOPHAGEAL JUNCTION BY THE STAPLE LINE ON EARLY POSTOPERATIVE CT SCANS AND THE DEVELOPMENT OF GASTRIC LEAK AFTER SG. THESE RESULTS SUPPORT THE VASCULAR THEORY AS ONE OF THE CAUSES OF LEAK AFTER SG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2950988 | ECHELON ENDOPATH STAPLER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |