ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2019-00776
- Event Type
- Injury
- Date Received
- December 24, 2019
- Date of Event
- November 4, 2019
- Report Date
- June 9, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002238135
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K) #: K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #: K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K)#: K163018. DEVICE EVALUATION: THE ZILBS-635-8-10 DEVICE OF LOT NUMBER: C1552921 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 09JAN2020. THERE WAS COMPRESSION OF THE DELIVERY SYSTEM DISTAL TO THE HANDLE. THE WAS SEPARATION OF THE OUTER SHEATH AT APPROXIMATELY 27CM FROM THE DISTAL END OF THE SHEATH. THE STENT WAS FRACTURED. AT THE DISTAL END OF THE SHEATH THERE WAS CRINKLING. ALL THE FAILURE MODES WERE LINKED. THE COMPLAINT DESCRIPTION STATES THAT THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. THE COMPRESSION AND CRINKLING MAY HAVE BEEN CAUSED BY TORTUROUS ANATOMY. THIS MAY HAVE LEAD TO THE SEPARATION OF THE OUTER SHEATH. THE SEPARATION OF THE OUTER SHEATH MAY HAVE LED TO THE DEPLOYMENT DIFFICULTIES WHICH IS WHY THE STENT WOULD NOT DEPLOY. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-8-10 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 RELEVANT MANUFACTURING RECORDS (C1552921) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER: C1552921. AS PER REGULATORY INPUT THE DEVICE WAS USED OFF LABEL AS SIDE BY SIDE TECHNIQUE IS NOT LICENCED IN JAPAN. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE USER PLACING THE STENTS IN A SIDE-BY-SIDE MANNER WHICH IS OFF-LABEL USE. THIS IS NOT PERMITTED. THE COMPLAINT DESCRIPTION STATES THAT THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. THE COMPRESSION AND CRINKLING MAY HAVE BEEN CAUSED BY TORTUROUS ANATOMY AS THE DEVICE WAS USED OFF LABEL. THIS MAY HAVE LEAD TO THE SEPARATION OF THE OUTER SHEATH. THE SEPARATION OF THE OUTER SHEATH MAY HAVE LED TO THE DEPLOYMENT DIFFICULTIES WHICH IS WHY THE STENT WOULD NOT DEPLOY. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
FDA MDR REPORT SUBMITTED ON 20-JAN-2020 UPDATED REPORT TO SERIOUS INJURY REPORT FOLLOWING ADDITIONAL INFO RECEIVED. FINAL REPORT WAS SUBMITTED AS A MALFUNCTION REPORT IN ERROR. THIS REPORT IS BEING SUBMITTED AS A CORRECTION REPORT. PMA/510(K) #: K163018. DEVICE EVALUATION THE ZILBS-635-8-10 DEVICE OF LOT NUMBER C1552921 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 09 JAN 2020. THERE WAS COMPRESSION OF THE DELIVERY SYSTEM DISTAL TO THE HANDLE. THE WAS SEPARATION OF THE OUTER SHEATH AT APPROXIMATELY 27CM FROM THE DISTAL END OF THE SHEATH. THE STENT WAS FRACTURED. AT THE DISTAL END OF THE SHEATH THERE WAS CRINKLING. ALL THE FAILURE MODES WERE LINKED. THE COMPLAINT DESCRIPTION STATES THAT THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. THE COMPRESSION AND CRINKLING MAY HAVE BEEN CAUSED BY TORTUROUS ANATOMY. THIS MAY HAVE LEAD TO THE SEPARATION OF THE OUTER SHEATH. THE SEPARATION OF THE OUTER SHEATH MAY HAVE LED TO THE DEPLOYMENT DIFFICULTIES WHICH IS WHY THE STENT WOULD NOT DEPLOY. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZILBS-635-8-10 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 RELEVANT MANUFACTURING RECORDS (B)(4) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1552921. AS PER REGULATORY INPUT THE DEVICE WAS USED OFF LABEL AS SIDE BY SIDE TECHNIQUE IS NOT LICENCED IN JAPAN. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE USER PLACING THE STENTS IN A SIDE-BY-SIDE MANNER WHICH IS OFF-LABEL USE. THIS IS NOT PERMITTED.THE COMPLAINT DESCRIPTION STATES THAT THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. THE COMPRESSION AND CRINKLING MAY HAVE BEEN CAUSED BY TORTUROUS ANATOMY AS THE DEVICE WAS USED OFF LABEL. THIS MAY HAVE LEAD TO THE SEPARATION OF THE OUTER SHEATH. THE SEPARATION OF THE OUTER SHEATH MAY HAVE LED TO THE DEPLOYMENT DIFFICULTIES WHICH IS WHY THE STENT WOULD NOT DEPLOY. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
LHD=LEFT HEPATIC DUCT, RHD=RIGHT HEPATIC DUCT, RPSD=RIGHT POSTERIOR SECTORAL DUCT, RASD=RIGHT ANTERIOR SECTORAL DUCT. THREE ZILVER 635 WERE USED WITH SBS (SIDE-BY-SIDE TECHNIQUE) IN THE FOLLOWING ORDER. THIS PATIENT HAD STENOSIS AROUND BIFURCATION OF LHD AND RHD (ESPECIALLY IN THE ORIGIN OF LHD). 1.TWO DELIVERY SYSTEMS OF ZILVER 635 WERE DELIVERED TO RASD AND RPSD. ZILVER 635 IN RASD WAS DEPLOYED FIRST AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY WHILE ANOTHER DELIVERY SYSTEM IN THE RPSD WAS REMAINED THERE. 2.IN ORDER TO PLACE STENTS IN RPSD AND LHD WITH SBS, THE USER ATTEMPTED TO ADVANCE ANOTHER ZILVER 635 DELIVERY SYSTEM TO LHD BUT HE COULD NOT DO THAT. THEREFORE THE DELIVERY SYSTEM IN RPSD AND LHD WERE REMOVED FROM THE BODY AND THE USER PERFORMED BALLOON INFLATION OF RPSD AND LHD WITH KANEKA MEDICS'S BALLOON(REN 4MM). 3.THEN THE USER COULD SOMEHOW DELIVER TWO DELIVERY SYSTEMS IN RPSD AND LHD. 4.THE USER STARTED TO DEPLOY THE STENT (ZILBS-635-8-10/LOT C1552921) IN RPSD. THE USER DID NOT FEEL ANY RESISTANCE DURING THE DEPLOYMENT BUT THE HANDLE SUDDENLY STOPPED MOVING WHEN THE SHEATH TIP REACHED AROUND THE BIFURCATION. THE USER WAS NOT ABLE TO FULLY DEPLOY THE STENT, SO HE HAD TO WITHDRAW THE WHOLE DELIVERY SYSTEM. THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. 5.AFTER THAT, THE USER DEPLOYED THE STENT IN LHD AND THE PROXIMAL END OF THE STENT WERE AT THE SAME LEVEL(POSITION) OF THE PROXIMAL END OF THE STENT IN RPSD. THE STENT IN RPSD GOT FRACTURED BUT IT COVERED TO THE BIFURCATION AND DRAINAGE WAS CONFIRMED, SO THE USER DECIDED TO OBSERVE PATIENT'S CONDITION AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. [05DEC2019 SHOHEI KON] DRAINAGE OF RPSD HAS STOPPED AND ADDITIONAL PROCEDURE WILL BE PERFORMED. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE ALSO REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE'.
LHD=LEFT HEPATIC DUCT, RHD=RIGHT HEPATIC DUCT, RPSD=RIGHT POSTERIOR SECTORAL DUCT, RASD=RIGHT ANTERIOR SECTORAL DUCT THREE ZILVER 635 WERE USED WITH SBS (SIDE-BY-SIDE TECHNIQUE) IN THE FOLLOWING ORDER. THIS PATIENT HAD STENOSIS AROUND BIFURCATION OF LHD AND RHD (ESPECIALLY IN THE ORIGIN OF LHD). 1. TWO DELIVERY SYSTEMS OF ZILVER 635 WERE DELIVERED TO RASD AND RPSD. ZILVER 635 IN RASD WAS DEPLOYED FIRST AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY WHILE ANOTHER DELIVERY SYSTEM IN THE RPSD WAS REMAINED THERE. 2. IN ORDER TO PLACE STENTS IN RPSD AND LHD WITH SBS, THE USER ATTEMPTED TO ADVANCE ANOTHER ZILVER 635 DELIVERY SYSTEM TO LHD BUT HE COULD NOT DO THAT. THEREFORE THE DELIVERY SYSTEM IN RPSD AND LHD WERE REMOVED FROM THE BODY AND THE USER PERFORMED BALLOON INFLATION OF RPSD AND LHD WITH KANEKA MEDICS'S BALLOON(REN 4MM). 3. THEN THE USER COULD SOMEHOW DELIVER TWO DELIVERY SYSTEMS IN RPSD AND LHD. 4. THE USER STARTED TO DEPLOY THE STENT (ZILBS-635-8-10/LOT C1552921) IN RPSD. THE USER DID NOT FEEL ANY RESISTANCE DURING THE DEPLOYMENT BUT THE HANDLE SUDDENLY STOPPED MOVING WHEN THE SHEATH TIP REACHED AROUND THE BIFURCATION. THE USER WAS NOT ABLE TO FULLY DEPLOY THE STENT, SO HE HAD TO WITHDRAW THE WHOLE DELIVERY SYSTEM. THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. 5. AFTER THAT, THE USER DEPLOYED THE STENT IN LHD AND THE PROXIMAL END OF THE STENT WERE AT THE SAME LEVEL(POSITION) OF THE PROXIMAL END OF THE STENT IN RPSD. THE STENT IN RPSD GOT FRACTURED BUT IT COVERED TO THE BIFURCATION AND DRAINAGE WAS CONFIRMED, SO THE USER DECIDED TO OBSERVE PATIENT'S CONDITION AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. [(B)(6) 2019 (B)(6)]: DRAINAGE OF RPSD HAS STOPPED AND ADDITIONAL PROCEDURE WILL BE PERFORMED. REPORT UPDATED TO SERIOUS INJURY REPORT. DEVICE EVALUATED ON 09-JAN-2020. ADDING PRECEDENCE FOR "DELIVERY SYSTEM KINKS" AND "FLEXOR BREAKING (FLEXOR/HANDLE SEPARATION)".
LHD=LEFT HEPATIC DUCT, RHD=RIGHT HEPATIC DUCT, RPSD=RIGHT POSTERIOR SECTORAL DUCT, RASD=RIGHT ANTERIOR SECTORAL DUCT. THREE ZILVER 635 WERE USED WITH SBS (SIDE-BY-SIDE TECHNIQUE) IN THE FOLLOWING ORDER. THIS PATIENT HAD STENOSIS AROUND BIFURCATION OF LHD AND RHD (ESPECIALLY IN THE ORIGIN OF LHD). 1. TWO DELIVERY SYSTEMS OF ZILVER 635 WERE DELIVERED TO RASD AND RPSD. ZILVER 635 IN RASD WAS DEPLOYED FIRST AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY WHILE ANOTHER DELIVERY SYSTEM IN THE RPSD WAS REMAINED THERE. 2. IN ORDER TO PLACE STENTS IN RPSD AND LHD WITH SBS, THE USER ATTEMPTED TO ADVANCE ANOTHER ZILVER 635 DELIVERY SYSTEM TO LHD BUT HE COULD NOT DO THAT. THEREFORE THE DELIVERY SYSTEM IN RPSD AND LHD WERE REMOVED FROM THE BODY AND THE USER PERFORMED BALLOON INFLATION OF RPSD AND LHD WITH KANEKA MEDICS'S BALLOON(REN 4MM). 3. THEN THE USER COULD SOMEHOW DELIVER TWO DELIVERY SYSTEMS IN RPSD AND LHD. 4. THE USER STARTED TO DEPLOY THE STENT (ZILBS-635-8-10 / LOT: C1552921) IN RPSD. THE USER DID NOT FEEL ANY RESISTANCE DURING THE DEPLOYMENT BUT THE HANDLE SUDDENLY STOPPED MOVING WHEN THE SHEATH TIP REACHED AROUND THE BIFURCATION. THE USER WAS NOT ABLE TO FULLY DEPLOY THE STENT, SO HE HAD TO WITHDRAW THE WHOLE DELIVERY SYSTEM. THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. 5. AFTER THAT, THE USER DEPLOYED THE STENT IN LHD AND THE PROXIMAL END OF THE STENT WERE AT THE SAME LEVEL (POSITION) OF THE PROXIMAL END OF THE STENT IN RPSD. THE STENT IN RPSD GOT FRACTURED BUT IT COVERED TO THE BIFURCATION AND DRAINAGE WAS CONFIRMED, SO THE USER DECIDED TO OBSERVE PATIENT'S CONDITION AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. [05DEC2019 SHOHEI KON]. DRAINAGE OF RPSD HAS STOPPED AND ADDITIONAL PROCEDURE WILL BE PERFORMED. [10MAR2020 SHOHEI KON]. ON (B)(6) 2020, ADDITIONAL PROCEDURE WAS PERFORMED. TWO BOSTON SCIENTIFIC'S HANAROSTENT WERE PLACED IN THE BILE DUCT. THE USER HAD TO USE BOSTON SCIENTIFIC'S SPYGLASS TO CHECK INSIDE OF THE FRACTURED STENT. ONE OF THE ADDITIONAL STENT WAS PLACED IN THE RPSD AND COVERED THE FRACTURED STENT. THE OTHER STENT WAS PLACED IN THE LHD. AFTER THE ADDITIONAL PROCEDURE, DRAINAGE OF RPSD HAS BEEN CONFIRMED AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL CLARIFICATION RECEIVED 10-MAR-2020: "THE ZILBS-635-8-10 / LOT: C1552921 (THE DEVICE RETURNED TO IRELAND) WAS FRACTURED DURING DEPLOYMENT AND THE OTHER SIDE OF THE STENT WAS LEFT IN PLACE, CAUSED A DRAINAGE FAILURE AND REQUIRED AN ADDITIONAL PROCEDURE."
FDA MDR REPORT SUBMITTED ON 20-JAN-2020 UPDATING REPORT TO SERIOUS INJURY REPORT. FINAL REPORT WAS SUBMITTED AS A MALFUNCTION REPORT IN ERROR. THIS REPORT IS BEING SUBMITTED AS A CORRECTION REPORT. LHD=LEFT HEPATIC DUCT, RHD=RIGHT HEPATIC DUCT, RPSD=RIGHT POSTERIOR SECTORAL DUCT, RASD=RIGHT ANTERIOR SECTORAL DUCT. THREE ZILVER 635 WERE USED WITH SBS (SIDE-BY-SIDE TECHNIQUE) IN THE FOLLOWING ORDER. THIS PATIENT HAD STENOSIS AROUND BIFURCATION OF LHD AND RHD (ESPECIALLY IN THE ORIGIN OF LHD). 1.TWO DELIVERY SYSTEMS OF ZILVER 635 WERE DELIVERED TO RASD AND RPSD. ZILVER 635 IN RASD WAS DEPLOYED FIRST AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY WHILE ANOTHER DELIVERY SYSTEM IN THE RPSD WAS REMAINED THERE. 2.IN ORDER TO PLACE STENTS IN RPSD AND LHD WITH SBS, THE USER ATTEMPTED TO ADVANCE ANOTHER ZILVER 635 DELIVERY SYSTEM TO LHD BUT HE COULD NOT DO THAT. THEREFORE THE DELIVERY SYSTEM IN RPSD AND LHD WERE REMOVED FROM THE BODY AND THE USER PERFORMED BALLOON INFLATION OF RPSD AND LHD WITH KANEKA MEDICS'S BALLOON(REN 4MM). 3.THEN THE USER COULD SOMEHOW DELIVER TWO DELIVERY SYSTEMS IN RPSD AND LHD. 4.THE USER STARTED TO DEPLOY THE STENT (ZILBS-635-8-10/LOT C1552921) IN RPSD. THE USER DID NOT FEEL ANY RESISTANCE DURING THE DEPLOYMENT BUT THE HANDLE SUDDENLY STOPPED MOVING WHEN THE SHEATH TIP REACHED AROUND THE BIFURCATION. THE USER WAS NOT ABLE TO FULLY DEPLOY THE STENT, SO HE HAD TO WITHDRAW THE WHOLE DELIVERY SYSTEM. THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. 5.AFTER THAT, THE USER DEPLOYED THE STENT IN LHD AND THE PROXIMAL END OF THE STENT WERE AT THE SAME LEVEL(POSITION) OF THE PROXIMAL END OF THE STENT IN RPSD. THE STENT IN RPSD GOT FRACTURED BUT IT COVERED TO THE BIFURCATION AND DRAINAGE WAS CONFIRMED, SO THE USER DECIDED TO OBSERVE PATIENT'S CONDITION AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. DRAINAGE OF RPSD HAS STOPPED AND ADDITIONAL PROCEDURE WILL BE PERFORMED. ON (B)(6) 2020 ADDITIONAL PROCEDURE WAS PERFORMED. TWO BOSTON SCIENTIFIC'S HANAROSTENT WERE PLACED IN THE BILE DUCT. THE USER HAD TO USE BOSTON SCIENTIFIC'S SPYGLASS TO CHECK INSIDE OF THE FRACTURED STENT. ONE OF THE ADDITIONAL STENT WAS PLACED IN THE RPSD AND COVERED THE FRACTURED STENT. THE OTHER STENT WAS PLACED IN THE LHD. AFTER THE ADDITIONAL PROCEDURE, DRAINAGE OF RPSD HAS BEEN CONFIRMED AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL CLARIFICATION RECEIVED (B)(6) 2020: "THE ZILBS-635-8-10/ LOT C1552921(THE DEVICE RETURNED TO IRELAND) WAS FRACTURED DURING DEPLOYMENT AND THE OTHER SIDE OF THE STENT WAS LEFT IN PLACE, CAUSED A DRAINAGE FAILURE AND REQUIRED AN ADDITIONAL PROCEDURE."
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
LHD=LEFT HEPATIC DUCT, RHD=RIGHT HEPATIC DUCT, RPSD=RIGHT POSTERIOR SECTORAL DUCT, RASD=RIGHT ANTERIOR SECTORAL DUCT. THREE ZILVER 635 WERE USED WITH SBS (SIDE-BY-SIDE TECHNIQUE) IN THE FOLLOWING ORDER. THIS PATIENT HAD STENOSIS AROUND BIFURCATION OF LHD AND RHD (ESPECIALLY IN THE ORIGIN OF LHD). TWO DELIVERY SYSTEMS OF ZILVER 635 WERE DELIVERED TO RASD AND RPSD. ZILVER 635 IN RASD WAS DEPLOYED FIRST AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY WHILE ANOTHER DELIVERY SYSTEM IN THE RPSD WAS REMAINED THERE. IN ORDER TO PLACE STENTS IN RPSD AND LHD WITH SBS, THE USER ATTEMPTED TO ADVANCE ANOTHER ZILVER 635 DELIVERY SYSTEM TO LHD BUT HE COULD NOT DO THAT. THEREFORE THE DELIVERY SYSTEM IN RPSD AND LHD WERE REMOVED FROM THE BODY AND THE USER PERFORMED BALLOON INFLATION OF RPSD AND LHD WITH KANEKA MEDICS'S BALLOON(REN 4MM). THEN THE USER COULD SOMEHOW DELIVER TWO DELIVERY SYSTEMS IN RPSD AND LHD. THE USER STARTED TO DEPLOY THE STENT (ZILBS-635-8-10/LOT C1552921) IN RPSD. THE USER DID NOT FEEL ANY RESISTANCE DURING THE DEPLOYMENT BUT THE HANDLE SUDDENLY STOPPED MOVING WHEN THE SHEATH TIP REACHED AROUND THE BIFURCATION. THE USER WAS NOT ABLE TO FULLY DEPLOY THE STENT, SO HE HAD TO WITHDRAW THE WHOLE DELIVERY SYSTEM. THE STENT GOT FRACTURED WHEN HE WITHDREW THE DELIVERY SYSTEM. AFTER THAT, THE USER DEPLOYED THE STENT IN LHD AND THE PROXIMAL END OF THE STENT WERE AT THE SAME LEVEL(POSITION) OF THE PROXIMAL END OF THE STENT IN RPSD. THE STENT IN RPSD GOT FRACTURED BUT IT COVERED TO THE BIFURCATION AND DRAINAGE WAS CONFIRMED, SO THE USER DECIDED TO OBSERVE PATIENT'S CONDITION AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. (B)(6). DRAINAGE OF RPSD HAS STOPPED AND ADDITIONAL PROCEDURE WILL BE PERFORMED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1311599 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G23813 | C1552921 | 10827002238135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |