UNKNOWN
Report
- Report Number
- 3001845648-2019-00730
- Event Type
- Injury
- Date Received
- December 16, 2019
- Date of Event
- December 15, 2016
- Report Date
- February 10, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- ESW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
THE 510(K) NUMBER COULD BE K162717 OR K093619, HOWEVER AS THE RPN HAS NOT BEEN PROVIDED IT CANNOT BE CONFIRMED. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. FACILITY DETAILS: DEPARTMENT OF GASTROENTEROLOGY, ENDOSCOPY DIVISION (1), DEPARTMENT OF GASTROENTEROLOGY, SURGERY DIVISION (2), CANCER (B)(6).
THIS IS A CORRECTION REPORT, CORRECTING REPORT DATE ABOVE TO THE 10-FEB-2020. THE EXACT RPN IS UNKNOWN. THE FOLLOWING 510 K#¿S ARE THE MOST LIKELY: K162717 OR K093619. DEVICE EVALUATION: THE EVO (EVOLUTION ESOPHAGEAL STENT) DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. SIXTY-THREE PATIENTS WERE INCLUDED A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY COLLECTED DATABASE INCLUDING ALL PATIENTS SUBMITTED TO ESOPHAGEAL STENT FOR PALLIATION OF MALIGNANT STRICTURES OR MALIGNANT FISTULAS BETWEEN FEBRUARY 2009 AND FEBRUARY 2014. MULTIPLE STENT BRAND WERE USED: WALLFLEX AND ULTRAFLEX [BOSTON SCIENTIFIC, WATERTOWN, MASS], EVOLUTION [WILSON COOK MEDICAL, LETCHWORTH, UK], HANAROSTENT [MI TECH], AND ENDOFLEX [VOERDE, GERMANY]). THIS FILE CAPTURES FISTULA. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO (EVOLUTION ESOPHAGEAL STENT) DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (EVOLUTION ESOPHAGEAL STENT) CONTROLLED-RELEASE STENT PARTIALLY COVERED) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0061-5, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : PERFORATION, HEMORRHAGE, ASPIRATION, REFLUX, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATION INCLUDE, BUT ARE NOT LIMITED TO: STENT MISPLACEMENT AND/OR MIGRATION; TUMOR INGROWTH OR OVERGROWTH; ESOPHAGEAL ULCERATION AND EROSION; NAUSEA; CHEST OR RETROSTERNAL PAIN; FOREIGN BODY SENSATION; FOOD BOLUS IMPACTION; GASBLOAT; SENSITIVITY TO METAL COMPONENTS; FISTULA INVOLVING TRACHEA, BRONCHI OR PLEURAL SPACE; INTESTINAL OBSTRUCTION SECONDARY TO MIGRATION; MEDIASTINITIS OR PERITONITIS; AIRWAY COMPRESSION; TRACHEAL OBSTRUCTION. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. THEREFORE RISK WILL NOT BE COMPLETE DUE TO THE LIMITATION OF AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, FISTULA INVOLVING TRACHEA ARE LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE EXACT RPN IS UNKNOWN. THE FOLLOWING 510 K#¿S ARE THE MOST LIKELY: K162717 OR K093619. DEVICE EVALUATION: THE EVO (EVOLUTION ESOPHAGEAL STENT) DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. SIXTY-THREE PATIENTS WERE INCLUDED A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY COLLECTED DATABASE INCLUDING ALL PATIENTS SUBMITTED TO ESOPHAGEAL STENT FOR PALLIATION OF MALIGNANT STRICTURES OR MALIGNANT FISTULAS BETWEEN FEBRUARY 2009 AND FEBRUARY 2014. MULTIPLE STENT BRAND WERE USED: WALLFLEX AND ULTRAFLEX [BOSTON SCIENTIFIC, WATERTOWN, MASS], EVOLUTION [WILSON COOK MEDICAL, LETCHWORTH, UK], HANAROSTENT [MI TECH], AND ENDOFLEX [VOERDE, GERMANY]). THIS FILE CAPTURES FISTULA. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO (EVOLUTION ESOPHAGEAL STENT) DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (EVOLUTION ESOPHAGEAL STENT) CONTROLLED-RELEASE STENT PARTIALLY COVERED) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0061-5, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : PERFORATION, HEMORRHAGE, ASPIRATION, REFLUX, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATION INCLUDE, BUT ARE NOT LIMITED TO: STENT MISPLACEMENT AND/OR MIGRATION; TUMOR INGROWTH OR OVERGROWTH; ESOPHAGEAL ULCERATION AND EROSION; NAUSEA; CHEST OR RETROSTERNAL PAIN; FOREIGN BODY SENSATION; FOOD BOLUS IMPACTION; GASBLOAT; SENSITIVITY TO METAL COMPONENTS; FISTULA INVOLVING TRACHEA, BRONCHI OR PLEURAL SPACE; INTESTINAL OBSTRUCTION SECONDARY TO MIGRATION; MEDIASTINITIS OR PERITONITIS; AIRWAY COMPRESSION; TRACHEAL OBSTRUCTION. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. THEREFORE RISK WILL NOT BE COMPLETE DUE TO THE LIMITATION OF AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, FISTULA INVOLVING TRACHEA ARE LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
ADVERSE EVENTS OF SELF-EXPANDABLE ESOPHAGEAL METALLIC STENTS IN PATIENTS WITH LONG-TERM SURVIVAL FROM ADVANCED MALIGNANT DISEASE. MEDEIROS 2017 FOR LESIONS LOCATED IN THE PROXIMAL ESOPHAGUS, WE USED A DEDICATED MODEL OF A PARTIALLY COVERED STENT WITH A LOWPROFILE, PROXIMAL FLARE SHAPE (CHOOSTENT; MI TECH, PYEONGTAEK, KOREA). FOR LESIONS LOCATED IN THE MID-ESOPHAGUS, WE USED A STANDARD PARTIALLY COVERED STENT OR, LESS OFTEN, A FULLY COVERED STENT, WITH AN 18- TO 23-MM BODY DIAMETER AND 23- TO 28-MM FLARE DIAMETER (WALLFLEX AND ULTRAFLEX [BOSTON SCIENTIFIC, WATERTOWN, MASS], EVOLUTION [WILSON COOK MEDICAL, LETCHWORTH, UK], HANAROSTENT [MI TECH], OR ENDOFLEX [VOERDE, GERMANY]). AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAILED ARTICLE FROM COOK EUROPE: STENT-INDUCED FISTULAS (COMPATIBLE CLINICAL SYMPTOMS ASSOCIATED WITH THE PRESENCE OF FISTULOUS ORIFICE DETECTED AT ENDOSCOPY) 13 CASES. STENT INDUCED FISTULA WAS MANAGED BY PLACEMENT OF ANOTHER STENT ON (B)(6). ''RESTENTING WAS PERFORMED FOR 7 PATIENTS FOR DUE TO STENT INDUCED FISTULAS''. STENT INDUCED FISTULA MANAGED BY PALLIATIVE CARE (NASOENTERAL TUBE OR GASTROSTOMY) ON (B)(6). CLINICAL ADVISOR HAS ASSIGNED SEVERITY OF 4 TO ALL THESE CASES SO CAPTURED IN THIS PR. CANNOT CONFIRM THAT AN EVO-PC/FC-E (UNKNOWN) WAS USED -FILE BEING OPENED CONSERVATIVELY.
THIS IS A CORRECTION REPORT, CORRECTING REPORT DATE ABOVE TO THE 10-FEB-2020. ADVERSE EVENTS OF SELF-EXPANDABLE ESOPHAGEAL METALLIC STENTS IN PATIENTS WITH LONG-TERM SURVIVAL FROM ADVANCED MALIGNANT DISEASE. MEDEIROS 2017. FOR LESIONS LOCATED IN THE PROXIMAL ESOPHAGUS, WE USED A DEDICATED MODEL OF A PARTIALLY COVERED STENT WITH A LOW PROFILE, PROXIMAL FLARE SHAPE (CHOOSTENT; MI TECH, PYEONGTAEK, KOREA). FOR LESIONS LOCATED IN THE MID-ESOPHAGUS, WE USED A STANDARD PARTIALLY COVERED STENT OR, LESS OFTEN, A FULLY COVERED STENT, WITH AN 18- TO 23-MM BODY DIAMETER AND 23- TO 28-MM FLARE DIAMETER (WALLFLEX AND ULTRAFLEX [BOSTON SCIENTIFIC, WATERTOWN, MASS], EVOLUTION [WILSON COOK MEDICAL, LETCHWORTH, UK], HANAROSTENT [MI TECH], OR ENDOFLEX [VOERDE, GERMANY]). AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAILED ARTICLE FROM COOK EUROPE. STENT-INDUCED FISTULAS (COMPATIBLE CLINICAL SYMPTOMS ASSOCIATED WITH THE PRESENCE OF FISTULOUS ORIFICE DETECTED AT ENDOSCOPY) 13 CASES. STENT INDUCED FISTULA WAS MANAGED BY PLACEMENT OF ANOTHER STENT ON (B)(6). ''RESTENTING WAS PERFORMED FOR 7 PATIENTS FOR DUE TO STENT INDUCED FISTULAS''. STENT INDUCED FISTULA MANAGED BY PALLIATIVE CARE (NASOENTERAL TUBE OR GASTROSTOMY) ON (B)(6). CLINICAL ADVISOR HAS ASSIGNED SEVERITY OF 4 TO ALL THESE CASES SO CAPTURED IN THIS PR. CANNOT CONFIRM THAT AN EVO-PC/FC-E (UNKNOWN) WAS USED -FILE BEING OPENED CONSERVATIVELY.
ADVERSE EVENTS OF SELF-EXPANDABLE ESOPHAGEAL METALLIC STENTS IN PATIENTS WITH LONG-TERM SURVIVAL FROM ADVANCED MALIGNANT DISEASE. MEDEIROS 2017. FOR LESIONS LOCATED IN THE PROXIMAL ESOPHAGUS, WE USED A DEDICATED MODEL OF A PARTIALLY COVERED STENT WITH A LOW PROFILE, PROXIMAL FLARE SHAPE (CHOOSTENT; MI TECH, PYEONGTAEK, KOREA). FOR LESIONS LOCATED IN THE MID-ESOPHAGUS, WE USED A STANDARD PARTIALLY COVERED STENT OR, LESS OFTEN, A FULLY COVERED STENT, WITH AN 18- TO 23-MM BODY DIAMETER AND 23- TO 28-MM FLARE DIAMETER (WALLFLEX AND ULTRAFLEX [BOSTON SCIENTIFIC, WATERTOWN, MASS], EVOLUTION [WILSON COOK MEDICAL, LETCHWORTH, UK], HANAROSTENT [MI TECH], OR ENDOFLEX [VOERDE, GERMANY]). AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAILED ARTICLE FROM COOK EUROPE. STENT-INDUCED FISTULAS (COMPATIBLE CLINICAL SYMPTOMS ASSOCIATED WITH THE PRESENCE OF FISTULOUS ORIFICE DETECTED AT ENDOSCOPY) 13 CASES. STENT INDUCED FISTULA WAS MANAGED BY PLACEMENT OF ANOTHER STENT ON (B)(6). ''RESTENTING WAS PERFORMED FOR 7 PATIENTS FOR DUE TO STENT INDUCED FISTULAS''. STENT INDUCED FISTULA MANAGED BY PALLIATIVE CARE (NASOENTERAL TUBE OR GASTROSTOMY) ON (B)(6). CLINICAL ADVISOR HAS ASSIGNED SEVERITY OF 4 TO ALL THESE CASES SO CAPTURED IN THIS PR. CANNOT CONFIRM THAT AN EVO-PC/FC-E (UNKNOWN) WAS USED -FILE BEING OPENED CONSERVATIVELY.
THE 510(K) NUMBER COULD BE K162717 OR K093619, HOWEVER AS THE RPN HAS NOT BEEN PROVIDED IT CANNOT BE CONFIRMED. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. FACILITY DETAILS: DEPARTMENT OF GASTROENTEROLOGY, ENDOSCOPY DIVISION (1), DEPARTMENT OF GASTROENTEROLOGY, SURGERY DIVISION (2), CANCER INSTITUTE OF THE UNIVERSITY OF (B)(6).
ADVERSE EVENTS OF SELF-EXPANDABLE ESOPHAGEAL METALLIC STENTS IN PATIENTS WITH LONG-TERM SURVIVAL FROM ADVANCED MALIGNANT DISEASE. MEDEIROS 2017 FOR LESIONS LOCATED IN THE PROXIMAL ESOPHAGUS, WE USED A DEDICATED MODEL OF A PARTIALLY COVERED STENT WITH A LOWPROFILE, PROXIMAL FLARE SHAPE (CHOOSTENT; MI TECH, (B)(4)). FOR LESIONS LOCATED IN THE MID-ESOPHAGUS, WE USED A STANDARD PARTIALLY COVERED STENT OR, LESS OFTEN, A FULLY COVERED STENT, WITH AN 18- TO 23-MM BODY DIAMETER AND 23- TO 28-MM FLARE DIAMETER (WALLFLEX AND ULTRAFLEX [BOSTON SCIENTIFIC, (B)(4)], EVOLUTION [WILSON COOK MEDICAL, (B)(4)], HANAROSTENT [(B)(4)], OR ENDOFLEX [(B)(4)]). AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAILED ARTICLE FROM COOK EUROPE: STENT-INDUCED FISTULAS (COMPATIBLE CLINICAL SYMPTOMS ASSOCIATED WITH THE PRESENCE OF FISTULOUS ORIFICE DETECTED AT ENDOSCOPY) - 13 CASES. STENT INDUCED FISTULA WAS MANAGED BY PLACEMENT OF ANOTHER STENT - (B)(6). ''RESTENTING WAS PERFORMED FOR 7 PATIENTS FOR DUE TO STENT INDUCED FISTULAS'' STENT INDUCED FISTULA MANAGED BY PALLIATIVE CARE (NASOENTERAL TUBE OR GASTROSTOMY) - (B)(6). CLINICAL ADVISOR HAS ASSIGNED SEVERITY OF 4 TO ALL THESE CASES SO CAPTURED IN THIS PR CANNOT CONFIRM THAT AN EVO-PC/FC-E (UNKNOWN) WAS USED -FILE BEING OPENED CONSERVATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1267855 | UNKNOWN | ESW PROSTHESIS, ESOPHAGEAL | ESW | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |