EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2022-00828
- Event Type
- Injury
- Date Received
- December 5, 2022
- Report Date
- January 25, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- ESW
- PMA / PMN Number
- K093619
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K162717. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K162717 DEVICE EVALUATION OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. THE DEVICE EVALUATION FOR THE EVO-FC-R-20-25-10-E DEVICE OF LOT C1483089 COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS OF LOT NUMBER C1483089 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL THE INSTRUCTIONS FOR USE, IFU0067 WHICH ACCOMPANIES THIS DEVICE, STATES ¿¿ THIS DEVICE IS USED TO MAINTAIN LUMINAL PATENCY OF THE ESOPHAGUS IN CASES OF; OBSTRUCTION CAUSE BY INTRINSIC OR EXTRINSIC MALIGNANCIES, REFRACTORY BENIGN STRICTURES, OR TO SEAL TRACHEOESOPHAGEAL FISTULAS.¿¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: N/A ROOT CAUSE ANALYSIS DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. THE INSTRUCTION FOR USE ADVISES THAT THE INTENDED USE ¿¿ THIS DEVICE IS USED TO MAINTAIN LUMINAL PATENCY OF THE ESOPHAGUS IN CASES OF; OBSTRUCTION CAUSE BY INTRINSIC OR EXTRINSIC MALIGNANCIES, REFRACTORY BENIGN STRICTURES, OR TO SEAL TRACHEOESOPHAGEAL FISTULAS.¿¿ IT IS KNOWN FROM THE AVAILABLE INFORMATION THAT THE STENT WAS USED TO TREAT A BENIGN FISTULA ESOPHAGEAL-JAJUNAL ANASTOMOSIS. IT IS LIKELY THE OFF-LABEL USE OF THE STENT WOULD HAVE CONTRIBUTED TO THE MIGRATION OF THE STENT. SUMMARY OF INVESTIGATION ACCORDING TO THE PMCF STUDY STENT MIGRATION OCCURRED 16 DAYS POST PLACEMENT OF THE STENT CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT THE STENT WAS REPOSITIONED AND REMAINED IN ITS ORIGINAL LOCATION AT 6 MONTHS POST PLACEMENT OR AT THE TIME OF DEATH. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. THE INSTRUCTION FOR USE ADVISES THAT THE INTENDED USE ¿¿ THIS DEVICE IS USED TO MAINTAIN LUMINAL PATENCY OF THE ESOPHAGUS IN CASES OF; OBSTRUCTION CAUSE BY INTRINSIC OR EXTRINSIC MALIGNANCIES, REFRACTORY BENIGN STRICTURES, OR TO SEAL TRACHEOESOPHAGEAL FISTULAS.¿¿ IT IS KNOWN FROM THE AVAILABLE INFORMATION THAT THE STENT WAS USED TO TREAT A BENIGN FISTULA ESOPHAGEAL-JAJUNAL ANASTOMOSIS. THE OFF-LABEL USE OF THE STENT WOULD HAVE CONTRIBUTED TO THE MIGRATION OF THE STENT. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION: THE 01X EVO-FC-R-20-25-10-E DEVICE OF LOT NUMBER C1483089 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO A PMCF STUDY ¿MDR-2054¿ TO CAPTURE 01 CASE OF STENT MIGRATION. THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS REVEALED A PACKAGING NON-CONFORMANCE (PAC-027) WAS IDENTIFIED DURING THE PACKAGING QC INSPECTION AT CIRL. THE NON-CONFORMANCE WAS IN RELATION TO 03X DEVICES WITH LOOSE FOREIGN MATTER (FM) IN THE PACKAGING. THE DEVICE WAS REWORKED AND WAS RE-INSPECTED AS PER CIRL PACKAGING QC PROCEDURE AND IS THEREFORE DEEMED NON-CONTRIBUTING TO THE COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL REVIEW: AS PER THE IFU (IFU0067), STENT MISPLACEMENT AND/OR MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH GI ENDOSCOPY ¿THOSE ASSOCIATED WITH GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HAEMORRHAGE, ASPIRATION, REFLUX, VOMITTING, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST." ¿ADDITIONAL ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO: AIRWAY COMPRESSION, ALLERGIC REACTION TO NICKEL, AORTOESOPHAGEAL FISTULA AND ARTERIOESOPHAGEAL FISTULA, CHEST OR RETROSTERNAL PAIN, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION) DYSPHAGIA, EDEMA, EROSION OR PERFORATION, ESOPHAGITIS, FISTULA INVOLVING TRACHEA OR BRONCHI OR PLEURAL SPACE, FOOD BOLUS IMPACTION, FOREIGN BODY SENSATION OR REACTION, GAS BLOAT, INADEQUATE STENT EXPANSION, INTESTINAL OBSTRUCTION SECONDARY TO MIGRATION, MEDIASTINITIS OR PERITONITIS, NAUSEA, PAIN/DISCOMFORT, REOCCLUSION, SENSITIVITY TO METAL COMPONENTS, SEPSIS, STENT MISPLACEMENT AND/OR MIGRATION, TRACHEAL OBSTRUCTION, TUMOUR OVERGROWTH, WIRE ENTRAPMENT.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR PRODUCT LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO A PROCEDURAL ADVERSE EVENT AND/OR PATIENT PRE-EXISTING CONDITIONS. AS PER THE INSTRUCTIONS FOR USE, STENT MIGRATION IS LISTED AS A POTENTIAL COMPLICATION FOLLOWING THE PLACEMENT OF THE DEVICE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 01X USED DEVICE. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AFTER MIGRATION, THE STENT WAS REPOSITIONED AND REMAINED IN ITS ORIGINAL LOCATION AT 6 MONTHS POST-PLACEMENT OR AT TIME OF DEATH. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PROCEDURE: WAS THE STENT PLACED AT THE INTENDED LOCATION AT COMPLETION OF THE PROCEDURE? YES. WERE ANY ADDITIONAL PROCEDURE (S) PERFORMED DURING THE STUDY PROCEDURE? NO. WERE ANY ADVERSE EVENTS DOCUMENTED DURING THE STENT PROCEDURE? NO. WERE ANY DEVICE DEFICIENCIES DOCUMENTED DURING THE PLACEMENT PROCEDURE? NO. ADVERSE EVENT: MIGRATION. ADVERSE EVENT ONSET (DAYS POST STENT PLACEMENT): 16. EVENT TREATMENT: ENDOSCOPIC-STUDY STENT REPOSITIONED. WAS THE EVENT CONSIDERED TO BE RELATED TO THE STUDY DEVICE? RELATED. IF RELATED, PLEASE PROVIDE A DETAIL DESCRIPTION OF HOW STUDY DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT: THE STENT MIGRATES AND IS REPOSITIONED. WAS THE EVENT CONSIDERED TO BE RELATED TO THE STUDY PROCEDURE? NOT RELATED. DID A PRE-EXISTING CONDITION, OR OTHER CONDITION OR CIRCUMSTANCE CAUSE OR CONTRIBUTE TO THIS EVENT? NO. DID THE EVENT OCCUR DUE TO A DEVICE DEFICIENCY? NO. EVENT STATUS AT TIME OF STUDY EXIT: RESOLVED (PATIENT RECOVERED/STABILIZED). AT THE CONCLUSION OF FOLLOW-UP WHAT WAS THE STATUS OF THE STUDY STENT: THE STENT REMAINED IN PLACE (OR INSIDE THE PATIENT) AT 6 MONTHS POST PLACEMENT OR AT THE TIME OF DEATH. ORIGINAL LOCATION.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE (B)(6) 2023.
THIS SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED DUE FILE CORRECTIONS MADE TO FAILURE MODE ON 25-JAN-2024
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2472043 | EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED | ESW PROSTHESIS, ESOPHAGEAL | ESW | COOK IRELAND LTD | C1483089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Required Intervention |