UNKNOWN
Report
- Report Number
- 1037905-2018-00420
- Event Type
- Injury
- Date Received
- September 14, 2018
- Report Date
- August 20, 2018
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
SRIRAM, P. V., RAMAKRISHNAN, A., RAO, G. V., & REDDY, D. N. (2004). SPONTANEOUS FRACTURE OF A BILIARY SELF-EXPANDING METAL STENT. ENDOSCOPY, 36(11), 1035-1036. DOI:10.1055/S-2004-825969 . HTTPS://WWW.THIEME-CONNECT.COM/PRODUCTS/EJOURNALS/ABSTRACT/10.1055/S-2004-825969. CONTINUED FROM SECTION B3 DATE OF EVENT: 2004. CONTINUED FROM SECTION G ALL MANUFACTURERS: 510(K)- K941350. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE PHOTOS PROVIDED IN THE ARTICLE, WE CANNOT COMPLETE A FULL EVALUATION; HOWEVER, WE CAN CONFIRM THE REPORT OF DEVICE FRAGMENTATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. COOK ENDOSCOPY ZA-STENT ENDOSCOPIC BILIARY STENT SYSTEMS WERE OBSOLETE IN 2005. THE INSTRUCTIONS FOR USE STATES UNDER POTENTIAL COMPLICATIONS, "ADDITIONAL COMPLICATIONS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM; OBSTUCTION OF THE PANCREATIC DUCT; STENT MIGRATION; TUMOR INGROWTH, TUMOR OVERGROWTH OF STENT ENDS, OR EXCESSIVE HYPERPLASTIC TISSUE INGROWTH." THE INSTRUCTIONS FOR USE STATES, "ZA-STENTS ARE INTENDED FOR PALLIATIVE TREATMENT ONLY. . . LONG TERM PATENCY WITH THIS STENT HAS NOT BEEN ESTABLISHED." ALL ZA-STENTS HAVE A THREE (3) YEAR EXPIRATION DATE; THEREFORE, ALL DEVICES DISTRIBUTED ARE BEYOND THEIR EXPECTED LIFE SPAN. PRIOR TO DISTRIBUTION, ALL ZA-STENT ENDOSCOPIC BILIARY STENT SYSTEMS WERE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BECAUSE COOK ENDOSCOPY ZA-STENTS WERE OBSOLETED IN 2005 AND ALL DISTRIBUTED DEVICES ARE BEYOND THEIR EXPECTED LIFE SPAN. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.
THE FOLLOWING WAS REPORTED ON 14-SEPTEMBER-2018: "DURING AN ENDOSCOPY, THE PHYSICIAN USED A COOK ZA-STENT ENDOSCOPIC BILIARY STENT SYSTEM [OBSOLETE AS OF 2008], AS DESCRIBED IN THE BELOW CASE REPORT EXCERPT. "A 63-YEAR-OLD WOMAN WITH DISTAL CHOLANGIOCARCINOMA, WHO HAD UNDERGONE PLACEMENT OF A ZA-STENT (WILSON-COOK MEDICAL INC., WINSTON-SALEM, NORTH CAROLINA, USA) 6 MONTHS PREVIOUSLY, PRESENTED WITH CHOLANGITIS. ON DUODENOSCOPY, THE STENT WAS FOUND TO BE CLOGGED WITH DEBRIS. IT HAD MIGRATED DISTALLY, AND IT APPEARED TO BE FRAGMENTED, WITH THE PROXIMAL END OF THE DISTAL SEGMENT ANCHORED TO THE AMPULLA BY A SINGLE STRAND. THIS FIRMLY EMBEDDED WIRE WAS CAREFULLY DETACHED AND THE DISTAL FRAGMENT WAS RETRIEVED WITH A RAT-TOOTH FORCEPS UNDER FLUOROSCOPIC CONTROL (SUBJECT OF THIS REPORT). A 10-FR COTTON-LEUNG BILIARY PLASTIC STENT (WILSON-COOK MEDICAL) WAS THEN INSERTED THROUGH THE REMAINING INTRABILIARY PORTION OF THE CLOGGED PROXIMAL FRAGMENT OF THE METALLIC STENT. TO THE BEST OF OUR KNOWLEDGE, SPONTANEOUS FRACTURE OF AN ENDOSCOPICALLY PLACED BILIARY SEMS HAS NOT BEEN PREVIOUSLY REPORTED. IN THE PATIENT PRESENTED HERE, WE DESCRIBE THE FIRST CASE OF A SPONTANEOUS FRACTURE OF A ZA-STENT, 6 MONTHS AFTER INSERTION. THIS STENT IS CONSTRUCTED OF ROUND SHAPE-RETAINING NICKEL-TITANIUM (NITINOL) WIRE TO PROVIDE SUPERIOR FLEXIBILITY AND SHAPE RETENTION WITHOUT SHORTENING, WHILE MINIMIZING THE RISK OF TISSUE DAMAGE. IN THIS CASE, IT IS CONCEIVABLE THAT THE MALIGNANT STRICTURE WAS TOO SOFT TO RETAIN THE STENT IN POSITION, LEADING TO DISTAL MIGRATION INTO THE DUODENAL LUMEN AT AN ACUTE ANGLE. THIS WOULD HAVE EXPOSED THE STENT TO THE SHEARING FORCES EXERTED BY DUODENAL PERISTALSIS, RESULTING IN STRESS FRACTURE AND EVENTUAL SEPARATION OF THE FRAGMENTS. HOWEVER, THE POSSIBILITY OF BILE-INDUCED CORROSION OF THE STENT CANNOT BE COMPLETELY RULED OUT." AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE MIGRATED PORTION OF THE STENT WAS REMOVED WITH RAT-TOOTH FORCEPS. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, BUT NO ADVERSE EFFECTS WERE REPORTED IN THE PUBLISHED CASE REPORT." COOK ENDOSCOPY DISCONTINUED THE MANUFACTURING OF THE ZA-STENT ENDOSCOPIC BILIARY STENT SYSTEMS IN 2005.
SRIRAM, P. V., RAMAKRISHNAN, A., RAO, G. V., & REDDY, D. N. (2004). SPONTANEOUS FRACTURE OF A BILIARY SELF-EXPANDING METAL STENT. ENDOSCOPY, 36(11), 1035-1036. DOI:10.1055/S-2004-825969. HTTPS://WWW.THIEME-CONNECT.COM/PRODUCTS/EJOURNALS/ABSTRACT/10.1055/S-2004-825969. DATE OF EVENT: 2004 ALL MANUFACTURERS: 510(K)- K941350. INVESTIGATION EVALUATION: THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH FURTHER INFORMATION. (B)(4).
DURING AN ENDOSCOPY, THE PHYSICIAN USED A COOK ZA-STENT ENDOSCOPIC BILIARY STENT SYSTEM [OBSOLETE AS OF 2008], AS DESCRIBED IN THE BELOW CASE REPORT EXCERPT. "A (B)(6)-YEAR-OLD WOMAN WITH DISTAL CHOLANGIOCARCINOMA, WHO HAD UNDERGONE PLACEMENT OF A ZA-STENT (WILSON-COOK MEDICAL INC., WINSTON-SALEM, NORTH CAROLINA, USA) 6 MONTHS PREVIOUSLY, PRESENTED WITH CHOLANGITIS. ON DUODENOSCOPY, THE STENT WAS FOUND TO BE CLOGGED WITH DEBRIS. IT HAD MIGRATED DISTALLY, AND IT APPEARED TO BE FRAGMENTED, WITH THE PROXIMAL END OF THE DISTAL SEGMENT ANCHORED TO THE AMPULLA BY A SINGLE STRAND. THIS FIRMLY EMBEDDED WIRE WAS CAREFULLY DETACHED AND THE DISTAL FRAGMENT WAS RETRIEVED WITH A RAT-TOOTH FORCEPS UNDER FLUOROSCOPIC CONTROL (SUBJECT OF THIS REPORT). A 10-FR COTTON-LEUNG BILIARY PLASTIC STENT (WILSON-COOK MEDICAL) WAS THEN INSERTED THROUGH THE REMAINING INTRABILIARY PORTION OF THE CLOGGED PROXIMAL FRAGMENT OF THE METALLIC STENT. TO THE BEST OF OUR KNOWLEDGE, SPONTANEOUS FRACTURE OF AN ENDOSCOPICALLY PLACED BILIARY SEMS HAS NOT BEEN PREVIOUSLY REPORTED. IN THE PATIENT PRESENTED HERE, WE DESCRIBE THE FIRST CASE OF A SPONTANEOUS FRACTURE OF A ZA-STENT, 6 MONTHS AFTER INSERTION. THIS STENT IS CONSTRUCTED OF ROUND SHAPE-RETAINING NICKEL-TITANIUM (NITINOL) WIRE TO PROVIDE SUPERIOR FLEXIBILITY AND SHAPE RETENTION WITHOUT SHORTENING, WHILE MINIMIZING THE RISK OF TISSUE DAMAGE. IN THIS CASE, IT IS CONCEIVABLE THAT THE MALIGNANT STRICTURE WAS TOO SOFT TO RETAIN THE STENT IN POSITION, LEADING TO DISTAL MIGRATION INTO THE DUODENAL LUMEN AT AN ACUTE ANGLE. THIS WOULD HAVE EXPOSED THE STENT TO THE SHEARING FORCES EXERTED BY DUODENAL PERISTALSIS, RESULTING IN STRESS FRACTURE AND EVENTUAL SEPARATION OF THE FRAGMENTS. HOWEVER, THE POSSIBILITY OF BILE-INDUCED CORROSION OF THE STENT CANNOT BE COMPLETELY RULED OUT." AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE MIGRATED PORTION OF THE STENT WAS REMOVED WITH RAT-TOOTH FORCEPS. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, BUT NO ADVERSE EFFECT WERE REPORTED IN THE PUBLISHED CASE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718869 | UNKNOWN | FGE, CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK ENDOSCOPY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | ENDOSCOPE, UNKNOWN MAKE OR MODEL |