EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

Report

Report Number: 3001845648-2016-00081
Event Type: Injury
Date Received: April 4, 2016
Date of Event: December 21, 2015
Report Date: March 9, 2016
Manufacturer: COOK IRELAND LTD
Product Code: FGE
UDI-DI: 10827002231341
Report Source: Manufacturer report
Reporter Location: CN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K)# OF SIMILAR DEVICE: K121430. THE COMPLAINT ISSUE WAS REPORTED AS FOLLOWS: STUDY: 10-014 EVOLUTION BILIARY STENT SYSTEM ¿ FULLY COVERED; (B)(6) - STENT MIGRATION, DISTAL. ¿UNDER CONSCIOUS SEDATION, ERCP REVEALED A BILIARY STRICTURE THAT MEASURED 3.0 CM IN LENGTH. THE STRICTURE WAS LOCATED IN THE COMMON BILE DUCT AT LEAST 2 CM BELOW THE HEPATIC BIFURCATION AND BELOW THE CYSTIC DUCT. MILD TORTUOSITY OF THE COMMON BILE DUCT WAS NOTED. SPHINCTEROTOMY WAS PERFORMED. PRE-STENT PLACEMENT DILATION WAS NOT PERFORMED. A 10 MM X 6 CM EVOLUTION BILIARY STENT-FULLY COVERED (C903727) WAS PLACED AT THE INTENDED LOCATION. STENT DEPLOYMENT WAS CONSIDERED EASY. AT THE COMPLETION OF THE STUDY PROCEDURE, THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND THERE WAS BOTH VISUAL AND FLUOROSCOPIC CONFIRMATION OF BILE FLOW. ON (B)(6) 2015 (30 DAYS POST-PROCEDURE), THE ONE MONTH TELEPHONE FOLLOW-UP WAS COMPLETED. THE PATIENT REPORTED NO SYMPTOMS. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. ON (B)(6) 2015 (36 DAYS POST-PROCEDURE), BLOOD WORK REVEALED A TOTAL BILIRUBIN OF 1.46 MG/DL, AN ALP OF 95 U/L, AND AN ALT OF 43 U/L. IT WAS NOTED AT THE 2, 4, 5, 6 AND 9 MONTH FOLLOW-UP CALLS THAT THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY). DURING THE 9 MONTH FOLLOW-UP CALL ON (B)(6) 2016, IT WAS LEARNED THAT THE PATIENT HAD BEEN DIAGNOSED WITH CHOLANGITIS ON (B)(6) 2015 AND HOSPITALIZED THE FOLLOWING DAY ON (B)(6) 2015. ON (B)(6) 2015 (195 DAYS POST-PROCEDURE), THE PATIENT DEVELOPED SYMPTOMS OF RECURRENT BILIARY OBSTRUCTION (MILD JAUNDICE, DARK URINE, PALE-COLORED STOOL). BLOOD WORK, DONE ON THE SAME DAY, REVEALED A TOTAL BILIRUBIN OF 3.86 MG/DL. CT CONFIRMED FULL (DOWNSTREAM) STENT MIGRATION AND THE SITE NOTED THE FOLLOWING, ¿VISUAL CONFIRMATION BY CT SCAN. STENT NO LONGER SEEN, EVACUATED.¿ TREATMENT INCLUDED ANTIBIOTIC THERAPY AND ENDOSCOPIC PLACEMENT OF A NON-STUDY STENT. THE CHOLANGITIS WAS NOTED TO HAVE RESOLVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. THE INVESTIGATOR INDICATED THAT THE EVENTS WERE NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE AND RESPONDED NO TO THE QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE?¿ THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. HOWEVER, AS INDICATED BY THE INVESTIGATOR THE EVENTS WERE NOT RELATED TO THE STUDY DEVICE AND THE DEVICE DID NOT MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED AS THE INVESTIGATOR INDICATED THAT THE EVENTS WERE NOT RELATED TO THE STUDY DEVICE AND THE DEVICE DID NOT MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE. AS PER THE INSTRUCTIONS FOR USE, POTENTIAL COMPLICATIONS INCLUDE MIGRATION. ALSO INFORMATION PROVIDED POST THE PROCEDURE NOTED AT THE 2, 4, 5, 6 AND 9 MONTH FOLLOW-UP CALLS THAT THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY). THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING ¿AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING.¿ PRIOR TO DISTRIBUTION ALL EVOLUTION DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-6-B DEVICE OF LOT C903727 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

Description of Event or Problem · 1

STUDY: 10-014 EVOLUTION BILIARY STENT SYSTEM - FULLY COVERED; (B)(6) - STENT MIGRATION, DISTAL. UNDER CONSCIOUS SEDATION, ERCP REVEALED A BILIARY STRICTURE THAT MEASURED 3.0 CM IN LENGTH. THE STRICTURE WAS LOCATED IN THE COMMON BILE DUCT AT LEAST 2 CM BELOW THE HEPATIC BIFURCATION AND BELOW THE CYSTIC DUCT. MILD TORTUOSITY OF THE COMMON BILE DUCT WAS NOTED. SPHINCTEROTOMY WAS PERFORMED. PRE-STENT PLACEMENT DILATION WAS NOT PERFORMED. A 10 MM X 6 CM EVOLUTION BILIARY STENT-FULLY COVERED (C903727) WAS PLACED AT THE INTENDED LOCATION. STENT DEPLOYMENT WAS CONSIDERED EASY. AT THE COMPLETION OF THE STUDY PROCEDURE, THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND THERE WAS BOTH VISUAL AND FLUOROSCOPIC CONFIRMATION OF BILE FLOW. ON (B)(6) 2015 (30 DAYS POST-PROCEDURE), THE ONE MONTH TELEPHONE FOLLOW-UP WAS COMPLETED. THE PATIENT REPORTED NO SYMPTOMS. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. ON (B)(6) 2015 (36 DAYS POST-PROCEDURE), BLOOD WORK REVEALED A TOTAL BILIRUBIN OF 1.46 MG/DL, AN ALP OF 95 U/L, AND AN ALT OF 43 U/L. IT WAS NOTED AT THE 2, 4, 5, 6 AND 9 MONTH FOLLOW-UP CALLS THAT THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY). DURING THE 9 MONTH FOLLOW-UP CALL ON (B)(6) 2016, IT WAS LEARNED THAT THE PATIENT HAD BEEN DIAGNOSED WITH CHOLANGITIS ON (B)(6) 2015 AND HOSPITALIZED THE FOLLOWING DAY ON (B)(6) 2015. ON (B)(6) 2015 (195 DAYS POST-PROCEDURE), THE PATIENT DEVELOPED SYMPTOMS OF RECURRENT BILIARY OBSTRUCTION (MILD JAUNDICE, DARK URINE, PALE-COLORED STOOL). BLOOD WORK, DONE ON THE SAME DAY, REVEALED A TOTAL BILIRUBIN OF 3.86 MG/DL. CT CONFIRMED FULL (DOWNSTREAM) STENT MIGRATION AND THE SITE NOTED THE FOLLOWING, "VISUAL CONFIRMATION BY CT SCAN. STENT NO LONGER SEEN, EVACUATED." TREATMENT INCLUDED ANTIBIOTIC THERAPY AND ENDOSCOPIC PLACEMENT OF A NON-STUDY STENT. THE CHOLANGITIS WAS NOTED TO HAVE RESOLVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. THE INVESTIGATOR INDICATED THAT THE EVENTS WERE NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE AND RESPONDED NO TO THE QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE?

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
201389	EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED		FGE	COOK IRELAND LTD			10827002231341

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention