ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2022-00540
- Event Type
- Malfunction
- Date Received
- August 18, 2022
- Date of Event
- October 7, 2020
- Report Date
- January 6, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) #K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #K182980. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. ¿SATO2021.PDF¿. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) STATES THE FOLLOWING: ¿THE ZILVER 518 AND 635 BILIARY STENT HAS BEEN DESIGNED FOR USE IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. THE JAPANESE PACKAGING INSERT C-CI0405D13 SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE INFORMATION FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE IN THE PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE HOWEVER, FROM THE INFORMATION PROVIDED THERE WAS PARTIAL STENT PLACEMENT IN THE JEJUNUM. AS PER PRODUCT MANAGER INPUT ¿I BELIEVE THAT THIS WOULD BE CONSIDERED OFF LABEL USE OF THE DEVICE¿ . SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER SATO ET AL ¿PERCUTANEOUS METALLIC STENT PLACEMENT FOR MALIGNANT AFFERENT LOOP SYNDROME VIA THE BLIND END OF THE JEJUNAL LIMB AFTER BILIARY RECONSTRUCTION¿. ACCORDING TO THE INITIAL REPORTER, A PATIENT DEATH OCCURRED HOWEVER THE PAPER REPORTED THAT THIS WAS DUE TO DISEASE PROGRESSION. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THE OFF LABEL USE OF 03 ZIB DEVICES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SATO ET AT 2021 - PERCUTANEOUS METALLIC STENT PLACEMENT FOR MALIGNANT AFFERENT LOOP SYNDROME VIA THE BLIND END OF THE JEJUNAL LIMB AFTER BILIARY RECONSTRUCTION PROCEDURE: PERCUTANEOUS METALLIC STENT PLACEMENT VIA THE JEJUNAL LIMB WAS PERFORMED IN FIVE MALE PATIENTS (MEDIAN AGE, 68 YEARS; RANGE, 51¿88 YEARS) WITH MALIGNANT AFFERENT LOOP SYNDROME FOLLOWING PANCREATODUODENECTOMY OR BILE DUCT RESECTION WITH RECONSTRUCTION AT OUR INSTITUTE FROM JUNE 2009 TO APRIL 2019. RECONSTRUCTION WAS PERFORMED USING A MODIFIED CHILD¿S METHOD OR THE ROUX-EN-Y METHOD, AND BLIND END OF THE JEJUNAL LIMB WAS SURGICALLY FIXED TO THE ABDOMINAL WALL. PERCUTANEOUS DRAINAGE OF THE AFFERENT LOOP WAS PERFORMED VIA THE BLIND END OF THE JEJUNAL LIMB. SUBSEQUENTLY, PERCUTANEOUS METALLIC STENT PLACEMENT WAS PERFORMED VIA THE SAME ROUTE. TECHNICAL SUCCESS, CLINICAL SUCCESS, AND COMPLICATIONS WERE RETROSPECTIVELY EVALUATED. METALLIC STENT PLACEMENT WAS ATTEMPTED VIA BEJL TO ACHIEVE DRAINAGE CATHETER REMOVAL. THE METALLIC STENT TYPE (ZILVER STENT: COOK, LIMERICK, IRELAND; NITI-S DUODENAL AND BILIARY STENT: TAE WOONG MEDICAL, GIMPO, KOREA; EGIS BILIARY STENT: S&G BIOTECH, YONGIN, KOREA) WAS DETERMINED BASED ON THE OBSTRUCTION SITE. WHEN THE METALLIC STENT WAS PLACED ACROSS THE HEPATICOJEJUNOSTO MY, A BARE BILIARY OR DUODENAL STENT WAS USED. WITH THE PATIENT IN THE SUPINE POSITION, A 0.035-INCH HYDROPHILIC GUIDE-WIRE (RADIO FOCUS M; TERUMO, TOKYO, JAPAN) WAS INSERTED VIA BEJL AND PASSED THROUGH THE OBSTRUCTED PORTION WITH A 6.5-F SEEKING CATHETER (HANAKO MEDICAL, SAITAMA, JAPAN) UNDER FLUOROSCOPIC GUIDANCE. A GUIDE-WIRE WAS EXCHANGED WITH A SUPER-STIFF GUIDE-WIRE (AMPLATZ EXTRA-STIFF WIRE, COOK MEDICAL, BLOOMINGTON, IN, USA), AND A METALLIC STENT DELIVERY SYSTEM WAS PASSED THROUGH THE OBSTRUCTED PORTION. AFTER DEPLOYING THE METALLIC STENT, THE SAFETY DRAINAGE CATHETER WAS PLACED. PATIENTS 1 & 4- TWO METALLIC STENTS WERE PLACED IN TANDEM USING THE STENT-IN-STENT METHOD FOR LONG-SEGMENT LESION. PATIENT #1: MS PLACEMENT (TYPE, DIAMETER/LENGTH) - ZILVER BILIARY STENT (BARE, 10 MM/80 MM) & ZILVER BILIARY STENT (BARE, 10 MM/40 MM) PLACED FOR BILE DUCT RESECTION USING ROUX-EN-Y RECONSTRUCTION + HEPATECTOMY ADDITIONAL PROCEDURE: MS PLACEMENT VIA PTBD - ANOTHER METALLIC STENT WAS PLACED IN PARALLEL VIA THE PTBD ROUTE AT THE SAME TIME AS THE PROCEDURE PERFORMED VIA BEJL. PATIENT #4: MS PLACEMENT (TYPE, DIAMETER/LENGTH) - ZILVER BILIARY STENT (BARE, 10 MM/80 MM) & NITI-S BILIARY STENT (COVERED, 10 MM/80 MM) PLACED FOR PANCREATODUODENECTOMY USING THE MODIFIED CHILD¿S RECONSTRUCTION. THIS COMPLAINT WAS OPENED TO CAPTURE THE VARIOUS OFF LABEL USES OF THE ZILVER BILIARY STENTS: USING ROUX-EN-Y RECONSTRUCTION METHOD. USING MODIFIED CHILD¿S RECONSTRUCTION. FOR PERCUTANEOUS METALLIC STENT PLACEMENT VIA THE JEJUNAL LIMB. SIDE-BY-SIDE STENT PLACEMENT (OFF LABEL IN JAPAN ONLY). PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENTS REPORTED.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED DUE TO AN UPDATE THE COMPLAINT DESCRIPTION. UPDATED COMPLAINT DESCRIPTION: SATO ET AT 2021 - PERCUTANEOUS METALLIC STENT PLACEMENT FOR MALIGNANT AFFERENT LOOP SYNDROME VIA THE BLIND END OF THE JEJUNAL LIMB AFTER BILIARY RECONSTRUCTION PROCEDURE: PERCUTANEOUS METALLIC STENT PLACEMENT VIA THE JEJUNAL LIMB WAS PERFORMED IN FIVE MALE PATIENTS (MEDIAN AGE, 68 YEARS; RANGE, 51¿88 YEARS) WITH MALIGNANT AFFERENT LOOP SYNDROME FOLLOWING PANCREATODUODENECTOMY OR BILE DUCT RESECTION WITH RECONSTRUCTION AT OUR INSTITUTE FROM (B)(6) 2009 TO (B)(6) 2019. RECONSTRUCTION WAS PERFORMED USING A MODIFIED CHILD¿S METHOD OR THE ROUX-EN-Y METHOD, AND BLIND END OF THE JEJUNAL LIMB WAS SURGICALLY FIXED TO THE ABDOMINAL WALL. PERCUTANEOUS DRAINAGE OF THE AFFERENT LOOP WAS PERFORMED VIA THE BLIND END OF THE JEJUNAL LIMB. SUBSEQUENTLY, PERCUTANEOUS METALLIC STENT PLACEMENT WAS PERFORMED VIA THE SAME ROUTE. TECHNICAL SUCCESS, CLINICAL SUCCESS, AND COMPLICATIONS WERE RETROSPECTIVELY EVALUATED. METALLIC STENT PLACEMENT WAS ATTEMPTED VIA BEJL TO ACHIEVE DRAINAGE CATHETER REMOVAL. THE METALLIC STENT TYPE (ZILVER STENT: COOK, LIMERICK, IRELAND; NITI-S DUODENAL AND BILIARY STENT: TAE WOONG MEDICAL, GIMPO, KOREA; EGIS BILIARY STENT: S&G BIOTECH, YONGIN, KOREA) WAS DETERMINED BASED ON THE OBSTRUCTION SITE. WHEN THE METALLIC STENT WAS PLACED ACROSS THE HEPATICOJEJUNOSTO MY, A BARE BILIARY OR DUODENAL STENT WAS USED. WITH THE PATIENT IN THE SUPINE POSITION, A 0.035-INCH HYDROPHILIC GUIDE-WIRE (RADIO FOCUS M; TERUMO, TOKYO, JAPAN) WAS INSERTED VIA BEJL AND PASSED THROUGH THE OBSTRUCTED PORTION WITH A 6.5-F SEEKING CATHETER (HANAKO MEDICAL, SAITAMA, JAPAN) UNDER FLUOROSCOPIC GUIDANCE. A GUIDE-WIRE WAS EXCHANGED WITH A SUPER-STIFF GUIDE-WIRE (AMPLATZ EXTRA-STIFF WIRE, COOK MEDICAL, BLOOMINGTON, IN, USA), AND A METALLIC STENT DELIVERY SYSTEM WAS PASSED THROUGH THE OBSTRUCTED PORTION. AFTER DEPLOYING THE METALLIC STENT, THE SAFETY DRAINAGE CATHETER WAS PLACED. PATIENTS 1 & 4- TWO METALLIC STENTS WERE PLACED IN TANDEM USING THE STENT-IN-STENT METHOD FOR LONG-SEGMENT LESION. PATIENT #1: MS PLACEMENT (TYPE, DIAMETER/LENGTH) - ZILVER BILIARY STENT (BARE, 10 MM/80 MM) & ZILVER BILIARY STENT (BARE, 10 MM/40 MM) PLACED FOR BILE DUCT RESECTION USING ROUX-EN-Y RECONSTRUCTION + HEPATECTOMY ADDITIONAL PROCEDURE: MS PLACEMENT VIA PTBD - ANOTHER METALLIC STENT WAS PLACED IN PARALLEL VIA THE PTBD ROUTE AT THE SAME TIME AS THE PROCEDURE PERFORMED VIA BEJL. PATIENT #4: MS PLACEMENT (TYPE, DIAMETER/LENGTH) - ZILVER BILIARY STENT (BARE, 10 MM/80 MM) & NITI-S BILIARY STENT (COVERED, 10 MM/80 MM) PLACED FOR PANCREATODUODENECTOMY USING THE MODIFIED CHILD¿S RECONSTRUCTION. THIS COMPLAINT WAS OPENED TO CAPTURE OFF LABEL USES OF THE ZILVER BILIARY STENTS- FOR PERCUTANEOUS METALLIC STENT PLACEMENT VIA THE JEJUNAL LIMB. OFF LABEL USE IS THE PARTIAL STENT PLACEMENT IN THE JEJUNUM. THE INVESTIGATION WAS CONCLUDED ON THE 13-JAN-2023 THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2379304 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |