ESW PROSTHESIS, ESOPHAGEAL
Report
- Report Number
- 3001845648-2019-00672
- Event Type
- Injury
- Date Received
- December 5, 2019
- Report Date
- May 25, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- ESW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
510(K) NUMBER CANNOT BE PROVIDED AS THE EXACT RPN IS UNKNOWN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS IS A CORRECTION REPORT. CORRECTING THE REPORTING REASON FROM ADVERSE EVENT AND PRODUCT PROBLEM TO JUST ADVERSE EVENT. PRODUCT PROBLEM WAS ADDED IN ERROR IN THE LAST REPORT. 510(K) NUMBER CANNOT BE PROVIDED AS THE EXACT RPN IS UNKNOWN. K093619 OR K162717 ARE THE MOST LIKELY US CLEARANCE NUMBERS. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER CANNOT BE PROVIDED AS THE EXACT RPN IS UNKNOWN. K093619 OR K162717 ARE THE MOST LIKELY US CLEARANCE NUMBERS. DEVICE EVALUATION: THE EVO (EVOLUTION ESOPHAGEAL METAL 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 TO ADDRESS "1 CASE LIFE THREATENING ASPIRATION PNEUMONIA" DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO (EVOLUTION ESOPHAGEAL METAL STENT) DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (EVOLUTION ESOPHAGEAL METAL STENT) 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, IFU0061-6, 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. ADDITIONAL INFORMATION WAS REQUESTED TO AID WITH THIS INVESTIGATION: " PLEASE NOTE SEVERAL FACTORS OR SITUATION COULD CAUSE ¿ASPIRATION PNEUMONIA¿ SUCH AS STENT DEPLOYED AT THE UPPER OR LOWER ESOPHAGEAL SPHINCTER, DYSPHAGIA CAUSED BY STENT OCCLUSION, PERFORATION BETWEEN ESOPHAGUS AND RESPIRATORY SYSTEM OR PROCEDURE-RELATED ASPIRATION. CAN YOU ASK WHICH WAS THE CASE THAT CAUSED THIS ASPIRATION PNEUMONIA?" HOWEVER ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED TO DATE, IF RECEIVED IN THE FUTURE THEN THE FILE WILL BE UPDATED ACCORDINGLY. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER MEDICAL ADVISOR "THIS INFORMATION IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT COOK STENT CAUSED LIFE THREATENING PNEUMONIA." THEREFORE DUE TO LIMITED INFORMATION AVAILABLE IT CANNOT BE CONFIRMED THAT COOK STENT CAUSED THE LIFE THREATENING ASPIRATION PNEUMONIA. SUMMARY: THE COMPLAINT IS NOT CONFIRMED DUE TO LIMITED INFORMATION AVAILABLE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K)#: K162717. THE DEVICE EVALUATION WAS UPDATED ON 25-MAY-2020. PLEASE SEE BELOW. DEVICE EVALUATION: THE EVO (EVOLUTION ESOPHAGEAL METAL 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 TO ADDRESS "1 CASE LIFE THREATENING ASPIRATION PNEUMONIA" DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO (EVOLUTION ESOPHAGEAL METAL STENT) DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (EVOLUTION ESOPHAGEAL METAL STENT) 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, IFU0061-6, 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. ADDITIONAL INFORMATION WAS REQUESTED TO AID WITH THIS INVESTIGATION: " PLEASE NOTE SEVERAL FACTORS OR SITUATION COULD CAUSE ¿ASPIRATION PNEUMONIA¿ SUCH AS STENT DEPLOYED AT THE UPPER OR LOWER ESOPHAGEAL SPHINCTER, DYSPHAGIA CAUSED BY STENT OCCLUSION, PERFORATION BETWEEN ESOPHAGUS AND RESPIRATORY SYSTEM OR PROCEDURE-RELATED ASPIRATION. CAN YOU ASK WHICH WAS THE CASE THAT CAUSED THIS ASPIRATION PNEUMONIA?" HOWEVER ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED TO DATE, IF RECIVED IN THE FUTURE THEN THE FILE WILL BE UPDATED ACCORDINGLY. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER MEDICAL ADVISOR "THIS INFORMATION IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT COOK STENT CAUSED LIFE THREATING PNEUMONIA." THEREFORE DUE TO LIMITED INFORMATION AVAILABLE IT CANNOT BE CONFIRMED THAT COOK STENT CAUSED THE LIFE THREATENING ASPIRATION PNEUMONIA. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. - ATTACHMENT: [JANG16 PREDICTORS OF ESOPHAGEAL SELF-EXPANDABLE METAL.PDF]
TITLE OF LITERATURE REVIEW: ¿¿PREDICATORS OF ESOPHAGEAL SELF-EXPANDABLE METAL STENT MIGRATION: AN ACADEMIC CENTER STUDY¿¿ JANG ET ALL 2016. COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON (B)(6) 2019. AS REPORTED TO CUSTOMER RELATIONS: "LIFE THREATENING ASPIRATION PNEUMONIA '' AS PER LITERATURE REVIEW JANG ET AL 2016 '' ''BASED ON PRE-DETERMINED DEFINITION OF SERIOUS ADVERSE EVENT , 6 CASES (5.7%) OF SERIOUS ADVERSE OUTCOMES WERE REPORTED'' INCLUDING; ''1 CASE OF LIFE THREATENING ASPIRATION PNEUMONIA WITHIN 24 HOURS OF STENT PLACEMENT'. THE CHOICE OF STENT TYPE (FULLY COVERED VS PARTIALLY COVERED), BRAND (WALLFLEX® [BOSTON SCI-ENTIFIC], EVOLUTION [COOK MEDICAL, BLOOMINGTON, IN, USA], HANARO® [M.I.TECH, PYEONGTAEK, KOREA], AND NITI-S® [TAEWOONG MEDICAL]), AND SIZE WAS DETERMINED BY THE PERFORMING ENDOSCOPIST.
TITLE OF LITERATURE REVIEW: ¿¿PREDICATORS OF ESOPHAGEAL SELF-EXPANDABLE METAL STENT MIGRATION: AN ACADEMIC CENTER STUDY¿¿ JANG ET ALL 2016. COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 20NOV2019. AS REPORTED TO CUSTOMER RELATIONS: "LIFE THREATENING ASPIRATION PNEUMONIA''. AS PER LITERATURE REVIEW JANG ET AL 2016 '' ''BASED ON PRE-DETERMINED DEFINITION OF SERIOUS ADVERSE EVENT , 6 CASES (5.7%) OF SERIOUS ADVERSE OUTCOMES WERE REPORTED'' INCLUDING; ''1 CASE OF LIFE THREATENING ASPIRATION PNEUMONIA WITHIN 24 HOURS OF STENT PLACEMENT'. THE CHOICE OF STENT TYPE (FULLY COVERED VS PARTIALLY COVERED), BRAND (WALLFLEX® [BOSTON SCI-ENTIFIC], EVOLUTION [COOK MEDICAL, BLOOMINGTON, IN, USA], HANARO® [M.I.TECH, PYEONGTAEK, KOREA], AND NITI-S® [TAEWOONG MEDICAL]), AND SIZE WAS DETERMINED BY THE PERFORMING ENDOSCOPIST.
TITLE OF LITERATURE REVIEW: ¿¿PREDICATORS OF ESOPHAGEAL SELF-EXPANDABLE METAL STENT MIGRATION: AN ACADEMIC CENTER STUDY¿¿ JANG ET ALL 2016. COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 20NOV2019. AS REPORTED TO CUSTOMER RELATIONS: "LIFE THREATENING ASPIRATION PNEUMONIA '' AS PER LITERATURE REVIEW JANG ET AL 2016 '' ''BASED ON PRE-DETERMINED DEFINITION OF SERIOUS ADVERSE EVENT , 6 CASES (5.7%) OF SERIOUS ADVERSE OUTCOMES WERE REPORTED'' INCLUDING; ''1 CASE OF LIFE THREATENING ASPIRATION PNEUMONIA WITHIN 24 HOURS OF STENT PLACEMENT' THE CHOICE OF STENT TYPE (FULLY COVERED VS PARTIALLY COVERED), BRAND (WALLFLEX® [BOSTON SCI-ENTIFIC], EVOLUTION [COOK MEDICAL, BLOOMINGTON, IN, USA], HANARO® [M.I.TECH, PYEONGTAEK, KOREA], AND NITI-S® [TAEWOONG MEDICAL]), AND SIZE WAS DETERMINED BY THE PERFORMING ENDOSCOPIST.
THIS FOLLOW UP IS BEING SUBMITTED DUE TO THE FOLLOWING CORRECTIONS: THE COMPLAINT WAS CHANGED FROM NOT CONFIRMED TO CONFIRMED - REFERENCE INVESTIGATION DETAILS UPDATED WITH THIS CHANGE IN SECTION H.
510(K) NUMBER CANNOT BE PROVIDED AS THE EXACT RPN IS UNKNOWN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
TITLE OF LITERATURE REVIEW: ¿¿PREDICATORS OF ESOPHAGEAL SELF-EXPANDABLE METAL STENT MIGRATION: AN ACADEMIC CENTER STUDY¿¿ JANG ET ALL 2016. COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 20NOV2019. AS REPORTED TO CUSTOMER RELATIONS: "LIFE THREATENING ASPIRATION PNEUMONIA. '' AS PER LITERATURE REVIEW JANG ET AL 2016 '' ''BASED ON PRE-DETERMINED DEFINITION OF SERIOUS ADVERSE EVENT , 6 CASES (5.7%) OF SERIOUS ADVERSE OUTCOMES WERE REPORTED'' INCLUDING; ''1 CASE OF LIFE THREATENING ASPIRATION PNEUMONIA WITHIN 24 HOURS OF STENT PLACEMENT.' THE CHOICE OF STENT TYPE (FULLY COVERED VS PARTIALLY COVERED), BRAND (WALLFLEX® [BOSTON SCI-ENTIFIC], EVOLUTION [COOK MEDICAL, BLOOMINGTON, IN, USA], HANARO® [M.I.TECH, PYEONGTAEK, KOREA], AND NITI-S® [TAEWOONG MEDICAL]), AND SIZE WAS DETERMINED BY THE PERFORMING ENDOSCOPIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1210107 | ESW PROSTHESIS, ESOPHAGEAL | ESW | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |