EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
Report
- Report Number
- 3001845648-2024-00802
- Event Type
- Injury
- Date Received
- December 11, 2024
- Date of Event
- June 19, 2013
- Report Date
- March 12, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- MUM
- PMA / PMN Number
- K163468
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FILE WAS RAISED FROM LITERATURE TO CAPTURE ADVERSE EVENTS, 2 CASES OF PERFORATION. DEVICE EVALUATION: THE EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED DEVICE OF UNKNOWN RPN AND UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS ASSOCIATED WITH THE FOLLOWING COMPLAINTS: (B)(4) TRINGALI ET AL 2014 - PERFORATION (#1 IT). (B)(4) TRINGALI ET AL 2014 - PERFORATION (#1 NL). (B)(4) TRINGALI ET AL 2014 - RE-OBSTRUCTION (#2 NL). (B)(4) TRINGALI ET AL 2014 - RE-OBSTRUCTION (#2 NL). (B)(4) TRINGALI ET AL 2014 - LOSS OF PATENCY (#4 NL). (B)(4) TRINGALI ET AL 2014 - PERFORATION (#1 IT). (B)(4) TRINGALI ET AL 2014 - RE-OBSTRUCTION (#2 IT). (B)(4) TRINGALI ET AL 2014 ¿ STENT MIGRATION (#3 IT). (B)(4) TRINGALI ET AL 2014 ¿ STENT MIGRATION (#3 CZ). (B)(4) TRINGALI ET AL 2014 - LOSS OF PATENCY (#4 IT). (B)(4) TRINGALI ET AL 2014 - LOSS OF PATENCY (#4 CZ). MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL EVOLUTION DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA ANALYSIS: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0053 WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: AIRWAY OBSTRUCTION, ALLERGIC REACTION TO CONTRAST OR MEDICATION, ASPIRATION, BILIARY OBSTRUCTION, CARDIAC ARRHYTHMIA OR ARREST, CHOLANGITIS, FEVER, HEMORRHAGE, HYPOTENSION, INFECTION, PERFORATION, REFLUX, RESPIRATORY DEPRESSION OR ARREST. ADDITIONAL ADVERSE EVENTS INCLUDE BUT ARE NOT LIMITED TO: ALLERGIC REACTION TO NICKEL, BOWEL IMPACTION, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION), EROSION OF THE LUMINAL MUCOSA, FOREIGN BODY SENSATION, INADEQUATE EXPANSION INTESTINAL PERFORATION, NAUSEA/VOMITING, PAIN/DISCOMFORT, PANCREATITIS, PRESSURE NECROSIS, SEPTICEMIA, STENT MISPLACEMENT AND/OR MIGRATION, STENT OCCLUSION, TUMOR INGROWTH OR OVERGROWTH, ULCERATION. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0053) LISTS ¿PERFORATION¿ AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO STENT PLACEMENT PROCEDURE. ALSO, AS PREVIOUSLY NOTED, ¿PERFORATION¿ IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE JOURNAL ARTICLE, PERFORATION HAS BEEN REPORTED. CONFIRMED QUANTITY OF (B)(4) USED DEVICE. ACCORDING TO THE MEDICAL ADVISOR¿S INPUT FOR PATIENT OUTCOME AND SEVERITY, HARM REQUIRING MEDICAL INTERVENTION WITHIN THE SAME OPERATING PROCEDURE, NO FURTHER HOSPITAL STAY REQUIRED. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO STENT PLACEMENT PROCEDURE. ALSO, AS PREVIOUSLY NOTED, ¿PERFORATION¿ IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.
PMA/510K#: K163468 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6)2025.
VAN HALSEMA ET AL 2018 (DIGITAL ACADEMIC REPOSITORY)- ENDOSCOPIC TREATMENT OF STENOSES AND LEAKS IN THE GASTROINTESTINAL TRACT - THE ROLE OF SELF-EXPANDABLE METAL STENTS - CHAPTER 7 THIS PROSPECTIVE, OBSERVATIONAL, MULTICENTER REGISTRY ENROLLED 108 PATIENTS WHO REQUIRED PALLIATIVE TREATMENT FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION BETWEEN DECEMBER 2009 AND JUNE 2011. SIX HOSPITALS IN 5 COUNTRIES PARTICIPATED IN THIS TRIAL, AND APPROVAL WAS OBTAINED FROM EACH SITE¿S ETHICS COMMITTEE OR INSTITUTIONAL REVIEW BOARD. PATIENTS WERE NOT ENROLLED IF THEY HAD A BENIGN CAUSE OF STRICTURE OR OBSTRUCTION, ENTERAL ISCHEMIA, SUSPECTED OR IMPENDING SMALL-BOWEL PERFORATION, COAGULOPATHY, INTRAABDOMINAL ABSCESS OR PERFORATION, CONDITIONS THAT PRECLUDED ENDOSCOPIC THERAPY, OR STRICTURES THAT DID NOT ALLOW PASSAGE OF A GUIDEWIRE OR STENT. PATIENTS UNDERWENT PLACEMENT OF THE EVOLUTION DUODENAL STENT (COOK IRELAND, LIMERICK, IRELAND) IN ACCORDANCE WITH STANDARD MEDICAL PRACTICE OF THE SITE, THE INVESTIGATOR, AND THE DEVICE INSTRUCTIONS FOR USE. THE EVOLUTION DUODENAL STENT IS AN UNCOVERED, SELF-EXPANDABLE METAL STENT CONSTRUCTED FROM A SINGLE WOVEN NITINOL WIRE. THE STENT IS MANUFACTURED IN LENGTHS OF 6, 9, AND 12 CM. ALL STENTS HAVE A BODY DIAMETER OF 22 MM AND A FLARE DIAMETER OF 27 MM AT THE PROXIMAL AND DISTAL ENDS. THE STENT INTRODUCER SYSTEM ACCEPTS A 0.035-INCH GUIDEWIRE AND IS INSERTED THROUGH AT LEAST A 3.7-MM WORKING CHANNEL OF A THERAPEUTIC ENDOSCOPE. THE DELIVERY HANDLE FACILITATES SINGLE-HANDED STENT DEPLOYMENT AND RECAPTURE, IF STENT REPOSITIONING IS NEEDED DURING DEPLOYMENT. THIS COMPLAINT WAS OPENED TO CAPTURE 2 CASES X PERFORATION. COUNTRY OF ORIGIN OF THE COMPLAINT IS UNKNOWN. THIS COMPLAINT WAS OPENED TO CONSERVATIVELY ADDRESS THE POTENTIAL THIS EVENT OCCURRED IN THE US. NO INFORMATION ON PATIENT OUTCOME SUPPLIED IN THE ARTICLE. THE MEAN PATIENT AGE WAS 65.8 _ 13.0 YEARS (RANGE 34-93 YEARS) AND 51.9% OF PATIENTS WERE MALE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2596662 | EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED | MUM STENT, METALIC EXPANDABLE, DUODENAL | MUM | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention |