ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2017-00256
- Event Type
- Injury
- Date Received
- July 3, 2017
- Date of Event
- June 5, 2017
- Report Date
- December 6, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002314860
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4) PMA/510(K) #K040505, K163169 THIS SPECIFIC ZIB6 DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. DEVICE EVALUATION THE ZIB6-40-6.0-40 DEVICE OF LOT NUMBER C1246814 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. FROM CUSTOMER TESTIMONY, IT IS NOT KNOWN IF THE PATIENT REQUIRED ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE, BUT THERE WAS NO IMPROVEMENT OF THE PATIENT CONDITION AFTER IMPLANTING THE STENT. THE TARGET FOR THE COMPLAINT DEVICE WAS THE BILE DUCT, VIA TRANSCUTANEOUS INSERTION. THE PATIENT HAD PREVIOUS SURGERY TO REMOVE THE DUODENUM AND REPLACE WITH THE INTESTINAL JEJUNUM, RESULTING IN SEVERELY TORTUOUS ANATOMY AT THE LOCATION OF THE LESION. THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN TERUMO/RADIOFOCUS WIRE GUIDE. IT IS UNKNOWN IF PRE-DILATION OR DEVICE FLUSHING WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. IT IS UNKNOWN IF THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: IMAGING FROM BILIARY STENTING IMPLANTATION IS PROVIDED ALONG WITH THE COMPLAINT REPORT. ACCESS WAS LIKELY THROUGH A PERCUTANEOUS GASTROSTOMY BECAUSE ONE IMAGE SUGGESTED GASTRIC FOLDS. ALTERNATIVELY, BUT LESS LIKELY, THE ACCESS WAS THROUGH A JEJUNOSTOMY. THE BILIARY TREE WAS SHORTER THAN USUAL AND IN AN UNUSUAL HORIZONTAL LOCATION WITH ANATOMY MOST CONSISTENT WITH PRIOR LIVER TRANSPLANTATION, ALTHOUGH BILIARY STENT IMPLANTATION IN BENIGN DISEASE IS UNUSUAL. A MASS DISTORTING THE DUODENAL C-SWEEP WAS ALSO POSSIBLE AND WOULD BE MORE CONSISTENT WITH METALLIC BILIARY STENT IMPLANTATION. THE BILIARY TREE WAS OPACIFIED WITH AN OCCLUDING BALLOON AND THEN STENT IMPLANTATION ATTEMPTED. ONE IMAGE OF THE STENT DEPLOYED TO 30MM AT THE POINT OF DELIVERY SYSTEM ENTRAPMENT WAS PROVIDED. THE STENT APPEARED NORMAL ALTHOUGH THE TIP OF THE DELIVERY SHEATH WAS TIPPED TO THE LEFT RATHER THAN ALIGNED WITH THE STENT'S LONG AXIS. (FIG 1) THE REMAINING IMAGES DEMONSTRATE STENT CONSTRICTION BY THE SEPARATED DELIVERY SHEATH TIP AS WELL AS THE FRACTURED DELIVERY SYSTEM TIP. (FIG 2) IMPRESSION : THE DISTAL DELIVERY SHEATH RING WAS ENTRAPPED BY THE STENT DURING UNSHEATHING, PRODUCING THE RING'S TIPPED APPEARANCE. THE ONLY CHOICES AVAILABLE TO THE OPERATOR WERE TO ATTEMPT PULLING THE ENTIRE STENT OUT OF THE BILIARY DUCT OR TO FORCIBLY ATTEMPT TO COMPLETE STENT DEPLOYMENT. IN RETROSPECT, PULLING THE STENT INTO THE BOWEL OR PURPOSELY FRACTURING IT MAY HAVE BEEN A BETTER OPTION. THE STENT COULD STILL BE FRACTURED AND PULLED INTO THE BOWEL WITH A BALLOON OR POSSIBLY A SNARE AS ONE CENTIMETER OF STENT DOES PROJECT INTO THE BOWEL. IT COULD ALSO BE POSSIBLE WITH SOME BENCH TESTING TO FRACTURE THE MARKER RING WIT H A CORONARY ANGIOPLASTY BALLOON SUCH AS A CORDIS EMERGE WHICH CAN GO THROUGH A SF SHEATH AND WITHSTAND 18ATM. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. A BETTER OUTCOME WOULD HAVE BEEN LIKELY HAD THE ENTIRE DELIVERY SYSTEM AND STENT BEEN PULLED INTO THE BOWEL EVEN IF THIS MEANT FRACTURING THE STENT. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE STENT AND DELIVERY SHEATH MARKER RING BECAME ENTRAPPED. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 22ND JUNE 2017. ON EVALUATION OF THE RETURNED DEVICE, THE FLEXOR WAS MEASURED AS 39.3CM, WHICH IS WITHIN SPECIFICATION OF 40CM +1.3CM -0.8CM. WITH THE HANDLE FULLY WITHDRAWN, THE FLEXOR MEASURED 44.4CM. THE FLEXOR WAS SEPARATED, WITH SOME UNCOILING DAMAGE (REF ATT. ¿IMAGES¿). THE COIL WAS CUT, AND THE FLEXOR WAS REMOVED. THERE WAS NO PUSHER RING OBSERVED ON THE INNER PEEK CATHETER. WITH THE HANDLE FULLY OPEN, THE INNER PEEK MEASURED 35.5CM. THE INNER PEEK WAS BROKEN PROXIMAL TO THE PUSHER RING. SOME MATERIAL BECAME DISLODGED. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FLEXOR WAS FOUND TO BE SEPARATED. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE SEVERELY TORTUOUS PATIENT ANATOMY. THE PATIENT HAD PREVIOUSLY BEEN TREATED WITH SURGERY TO REMOVE THE DUODENUM. THE PATIENT ANATOMY COULD HAVE APPLIED HIGH FORCES TO THE COMPLAINT DEVICE DURING DEPLOYMENT. THESE FORCES COULD HAVE CAUSED THE STENT AND DELIVERY SHEATH MARKER RING BECOMING ENTRAPPED, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE SHEATHS SEPARATING. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. DOCUMENT REVIEW ZIB6-40-6.0-40 DEVICE OF LOT NUMBER C1246814 CONTAINS (B)(4) (FLEXOR 40 6FR) OF (B)(4) AND (B)(4)(PEEK AND PUSHER RING ASSEMBLY) OF LOT CH1239039. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1246814 & CH1239039) DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE INCOMING QC INSPECTION RECORDS REVEALED NO ISSUES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1246814. SUMMARY THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FLEXOR WAS FOUND TO BE SEPARATED. ACCORDING TO THE INITIAL REPORTER, IT IS UNCLEAR IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING ASSESSED THE COMPLAINT AS PER QSI0413 AND THE RISK HAS BEEN DETERMINED TO BE MODERATE. NO IMMEDIATE ACTION IS REQUIRED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 PMA/510(K) #K040505, K163169 THIS SPECIFIC ZIB6 DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. DEVICE EVALUATION THE ZIB6-40-6.0-40 DEVICE OF LOT NUMBER C1246814 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. FROM CUSTOMER TESTIMONY, IT IS NOT KNOWN IF THE PATIENT REQUIRED ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE, BUT THERE WAS NO IMPROVEMENT OF THE PATIENT CONDITION AFTER IMPLANTING THE STENT. THE TARGET FOR THE COMPLAINT DEVICE WAS THE BILE DUCT, VIA TRANSCUTANEOUS INSERTION. THE PATIENT HAD PREVIOUS SURGERY TO REMOVE THE DUODENUM AND REPLACE WITH THE INTESTINAL JEJUNUM, RESULTING IN SEVERELY TORTUOUS ANATOMY AT THE LOCATION OF THE LESION. THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN TERUMO/RADIOFOCUS WIRE GUIDE. IT IS UNKNOWN IF PRE-DILATION OR DEVICE FLUSHING WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. IT IS UNKNOWN IF THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: 1. IMAGING FROM BILIARY STENTING IMPLANTATION IS PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. ACCESS WAS LIKELY THROUGH A PERCUTANEOUS GASTROSTOMY BECAUSE ONE IMAGE SUGGESTED GASTRIC FOLDS. ALTERNATIVELY, BUT LESS LIKELY, THE ACCESS WAS THROUGH A JEJUNOSTOMY. 3. THE BILIARY TREE WAS SHORTER THAN USUAL AND IN AN UNUSUAL HORIZONTAL LOCATION WITH ANATOMY MOST CONSISTENT WITH PRIOR LIVER TRANSPLANTATION, ALTHOUGH BILIARY STENT IMPLANTATION IN BENIGN DISEASE IS UNUSUAL. A MASS DISTORTING THE DUODENAL C-SWEEP WAS ALSO POSSIBLE AND WOULD BE MORE CONSISTENT WITH METALLIC BILIARY STENT IMPLANTATION. 4. THE BILIARY TREE WAS OPACIFIED WITH AN OCCLUDING BALLOON AND THEN STENT IMPLANTATION ATTEMPTED. 5. ONE IMAGE OF THE STENT DEPLOYED TO 30MM AT THE POINT OF DELIVERY SYSTEM ENTRAPMENT WAS PROVIDED. THE STENT APPEARED NORMAL ALTHOUGH THE TIP OF THE DELIVERY SHEATH WAS TIPPED TO THE LEFT RATHER THAN ALIGNED WITH THE STENT'S LONG AXIS. (FIG 1) 6. THE REMAINING IMAGES DEMONSTRATE STENT CONSTRICTION BY THE SEPARATED DELIVERY SHEATH TIP AS WELL AS THE FRACTURED DELIVERY SYSTEM TIP. (FIG 2) IMPRESSION : 1. THE DISTAL DELIVERY SHEATH RING WAS ENTRAPPED BY THE STENT DURING UNSHEATHING, PRODUCING THE RING'S TIPPED APPEARANCE. THE ONLY CHOICES AVAILABLE TO THE OPERATOR WERE TO ATTEMPT PULLING THE ENTIRE STENT OUT OF THE BILIARY DUCT OR TO FORCIBLY ATTEMPT TO COMPLETE STENT DEPLOYMENT. IN RETROSPECT, PULLING THE STENT INTO THE BOWEL OR PURPOSELY FRACTURING IT MAY HAVE BEEN A BETTER OPTION. THE STENT COULD STILL BE FRACTURED AND PULLED INTO THE BOWEL WITH A BALLOON OR POSSIBLY A SNARE AS ONE CENTIMETER OF STENT DOES PROJECT INTO THE BOWEL. IT COULD ALSO BE POSSIBLE WITH SOME BENCH TESTING TO FRACTURE THE MARKER RING WIT H A CORONARY ANGIOPLASTY BALLOON SUCH AS A CORDIS EMERGE WHICH CAN GO THROUGH A SF SHEATH AND WITHSTAND 18ATM. 2. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. 3. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. 4. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. A BETTER OUTCOME WOULD HAVE BEEN LIKELY HAD THE ENTIRE DELIVERY SYSTEM AND STENT BEEN PULLED INTO THE BOWEL EVEN IF THIS MEANT FRACTURING THE STENT. 5. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE STENT AND DELIVERY SHEATH MARKER RING BECAME ENTRAPPED. 6. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 22ND JUNE 2017. ON EVALUATION OF THE RETURNED DEVICE, THE FLEXOR WAS MEASURED AS 39.3CM, WHICH IS WITHIN SPECIFICATION OF 40CM +1.3CM -0.8CM. WITH THE HANDLE FULLY WITHDRAWN, THE FLEXOR MEASURED 44.4CM. THE FLEXOR WAS SEPARATED, WITH SOME UNCOILING DAMAGE (REF ATT. ¿IMAGES¿). THE COIL WAS CUT, AND THE FLEXOR WAS REMOVED. THERE WAS NO PUSHER RING OBSERVED ON THE INNER PEEK CATHETER. WITH THE HANDLE FULLY OPEN, THE INNER PEEK MEASURED 35.5CM. THE INNER PEEK WAS BROKEN PROXIMAL TO THE PUSHER RING. SOME MATERIAL BECAME DISLODGED. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FLEXOR WAS FOUND TO BE SEPARATED. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE SEVERELY TORTUOUS PATIENT ANATOMY. THE PATIENT HAD PREVIOUSLY BEEN TREATED WITH SURGERY TO REMOVE THE DUODENUM. THE PATIENT ANATOMY COULD HAVE APPLIED HIGH FORCES TO THE COMPLAINT DEVICE DURING DEPLOYMENT. THESE FORCES COULD HAVE CAUSED THE STENT AND DELIVERY SHEATH MARKER RING BECOMING ENTRAPPED, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE SHEATHS SEPARATING. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. DOCUMENT REVIEW: ZIB6-40-6.0-40 DEVICE OF LOT NUMBER C1246814 CONTAINS RMN#18-135 (FLEXOR 40 6FR) OF QC#245179 AND IRSP61338 (PEEK AND PUSHER RING ASSEMBLY) OF LOT CH1239039. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1246814 & CH1239039) DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE INCOMING QC INSPECTION RECORDS REVEALED NO ISSUES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1246814. SUMMARY: THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FLEXOR WAS FOUND TO BE SEPARATED. ACCORDING TO THE INITIAL REPORTER, IT IS UNCLEAR IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING ASSESSED THE COMPLAINT AS PER QSI0413 AND THE RISK HAS BEEN DETERMINED TO BE MODERATE. NO IMMEDIATE ACTION IS REQUIRED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 THIS SPECIFIC ZIB6 DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) #K040505, K163169 THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
THIS FOLLOW UP REPORT IS BEING SUBMITTED AS IMAGE REVIEW WAS RECEIVED. INITIAL REPORT DETAILS: ZILVER 635 SELF-EXPANDING BILIARY STENT WAS ADVANCED OVER THE WIRE GUIDE AND IT WAS ATTEMPTED TO DEPLOY. BUT AFTER THE STENT WAS DEPLOYED 3CM, THE USER COULD NOT DEPLOY THE STENT ANYMORE (THE HANDLE COULD NOT BE MANIPULATED). SO, HE REPLACED THE WIRE GUIDE FROM TERUMO/RADIFOCUS TO COIL WIRE GUIDE, HOWEVER THE SITUATION DID NOT CHANGE. SINCE THE DEVICE COULD NOT LEAVE IN THE PATIENTS' BODY, HE PULLED THE OUTER SHEATH (INTRODUCER CATHETER) TO DEPLOY THE STENT. THEN, THE OUTER SHEATH GOT SEPARATED AND REMAINED IN THE PATIENTS¿ BODY. SINCE SEPARATED PART OF THE OUTER SHEATH CONSTRICTED THE STENT, IT WAS DIFFICULT TO REMOVE THE INNER SHEATH. WHEN THE USER PULLED THE INNER SHEATH, THE TIP OF THE INNER SHEATH GOT SEPARATED AND REMAINED IN THE PLACED STENT. THE PROCEDURE ENDED AT THIS MOMENT, BUT THE FUTURE PROCEDURE IS UNDER CONSIDERATION.
THIS FOLLOW UP REPORT IS BEING SUBMITTED AS IMAGE REVIEW WAS RECEIVED. INITIAL REPORT DETAILS: ZILVER 635 SELF-EXPANDING BILIARY STENT WAS ADVANCED OVER THE WIRE GUIDE AND IT WAS ATTEMPTED TO DEPLOY. BUT AFTER THE STENT WAS DEPLOYED 3CM, THE USER COULD NOT DEPLOY THE STENT ANYMORE (THE HANDLE COULD NOT BE MANIPULATED). SO, HE REPLACED THE WIRE GUIDE FROM TERUMO/RADIFOCUS TO COIL WIRE GUIDE, HOWEVER THE SITUATION DID NOT CHANGE. SINCE THE DEVICE COULD NOT LEAVE IN THE PATIENTS' BODY, HE PULLED THE OUTER SHEATH (INTRODUCER CATHETER) TO DEPLOY THE STENT. THEN, THE OUTER SHEATH GOT SEPARATED AND REMAINED IN THE PATIENTS¿ BODY. SINCE SEPARATED PART OF THE OUTER SHEATH CONSTRICTED THE STENT, IT WAS DIFFICULT TO REMOVE THE INNER SHEATH. WHEN THE USER PULLED THE INNER SHEATH, THE TIP OF THE INNER SHEATH GOT SEPARATED AND REMAINED IN THE PLACED STENT. THE PROCEDURE ENDED AT THIS MOMENT, BUT THE FUTURE PROCEDURE IS UNDER CONSIDERATION.
ZILVER 635 SELF-EXPANDING BILIARY STENT WAS ADVANCED OVER THE WIRE GUIDE AND IT WAS ATTEMPTED TO DEPLOY. BUT AFTER THE STENT WAS DEPLOYED 3 CM, THE USER COULD NOT DEPLOY THE STENT ANYMORE (THE HANDLE COULD NOT BE MANIPULATED). SO, HE REPLACED THE WIRE GUIDE FROM TERUMO/RADIFOCUS TO COIL WIRE GUIDE, HOWEVER THE SITUATION DID NOT CHANGE. SINCE THE DEVICE COULD NOT LEAVE IN THE PATIENTS' BODY, HE PULLED THE OUTER SHEATH (INTRODUCER CATHETER) TO DEPLOY THE STENT. THEN, THE OUTER SHEATH GOT SEPARATED AND REMAINED IN THE PATIENTS' BODY. SINCE SEPARATED PART OF THE OUTER SHEATH CONSTRICTED THE STENT, IT WAS DIFFICULT TO REMOVE THE INNER SHEATH. WHEN THE USER PULLED THE INNER SHEATH, THE TIP OF THE INNER SHEATH GOT SEPARATED AND REMAINED IN THE PLACED STENT. THE PROCEDURE ENDED AT THIS MOMENT, BUT THE FUTURE PROCEDURE IS UNDER CONSIDERATION.
COOK (B)(4) LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS SPECIFIC ZIB6 DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) #K040505, K163169. THE ZIB6-40-6.0-40 DEVICE OF LOT NUMBER C1246814 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. FROM CUSTOMER TESTIMONY, IT IS NOT KNOWN IF THE PATIENT REQUIRED ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE, BUT THERE WAS NO IMPROVEMENT OF THE PATIENT CONDITION AFTER IMPLANTING THE STENT. THE TARGET FOR THE COMPLAINT DEVICE WAS THE BILE DUCT, VIA TRANSCUTANEOUS INSERTION. THE PATIENT HAD PREVIOUS SURGERY TO REMOVE THE DUODENUM AND REPLACE WITH THE INTESTINAL JEJUNUM, RESULTING IN SEVERELY TORTUOUS ANATOMY AT THE LOCATION OF THE LESION. THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN TERUMO/RADIOFOCUS WIRE GUIDE. IT IS UNKNOWN IF PRE-DILATION OR DEVICE FLUSHING WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. IT IS UNKNOWN IF THE HANDLE WAS PULLED TOWARDS THE HUB DURING DEPLOYMENT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: IMAGING FROM BILIARY STENTING IMPLANTATION IS PROVIDED ALONG WITH THE COMPLAINT REPORT. ACCESS WAS LIKELY THROUGH A PERCUTANEOUS GASTROSTOMY BECAUSE ONE IMAGE SUGGESTED GASTRIC FOLDS. ALTERNATIVELY, BUT LESS LIKELY, THE ACCESS WAS THROUGH A JEJUNOSTOMY. THE BILIARY TREE WAS SHORTER THAN USUAL AND IN AN UNUSUAL HORIZONTAL LOCATION WITH ANATOMY MOST CONSISTENT WITH PRIOR LIVER TRANSPLANTATION, ALTHOUGH BILIARY STENT IMPLANTATION IN BENIGN DISEASE IS UNUSUAL. A MASS DISTORTING THE DUODENAL C-SWEEP WAS ALSO POSSIBLE AND WOULD BE MORE CONSISTENT WITH METALLIC BILIARY STENT IMPLANTATION. THE BILIARY TREE WAS OPACIFIED WITH AN OCCLUDING BALLOON AND THEN STENT IMPLANTATION ATTEMPTED. ONE IMAGE OF THE STENT DEPLOYED TO 30MM AT THE POINT OF DELIVERY SYSTEM ENTRAPMENT WAS PROVIDED. THE STENT APPEARED NORMAL ALTHOUGH THE TIP OF THE DELIVERY SHEATH WAS TIPPED TO THE LEFT RATHER THAN ALIGNED WITH THE STENT'S LONG AXIS. THE REMAINING IMAGES DEMONSTRATE STENT CONSTRICTION BY THE SEPARATED DELIVERY SHEATH TIP AS WELL AS THE FRACTURED DELIVERY SYSTEM TIP. IMPRESSION: THE DISTAL DELIVERY SHEATH RING WAS ENTRAPPED BY THE STENT DURING UNSHEATHING, PRODUCING THE RING'S TIPPED APPEARANCE. THE ONLY CHOICES AVAILABLE TO THE OPERATOR WERE TO ATTEMPT PULLING THE ENTIRE STENT OUT OF THE BILIARY DUCT OR TO FORCIBLY ATTEMPT TO COMPLETE STENT DEPLOYMENT. IN RETROSPECT, PULLING THE STENT INTO THE BOWEL OR PURPOSELY FRACTURING IT MAY HAVE BEEN A BETTER OPTION. THE STENT COULD STILL BE FRACTURED AND PULLED INTO THE BOWEL WITH A BALLOON OR POSSIBLY A SNARE AS ONE CENTIMETER OF STENT DOES PROJECT INTO THE BOWEL. IT COULD ALSO BE POSSIBLE WITH SOME BENCH TESTING TO FRACTURE THE MARKER RING WITH A CORONARY ANGIOPLASTY BALLOON SUCH AS A CORDIS EMERGE WHICH CAN GO THROUGH A SF SHEATH AND WITHSTAND 18 ATM. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. A BETTER OUTCOME WOULD HAVE BEEN LIKELY HAD THE ENTIRE DELIVERY SYSTEM AND STENT BEEN PULLED INTO THE BOWEL EVEN IF THIS MEANT FRACTURING THE STENT. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE STENT AND DELIVERY SHEATH MARKER RING BECAME ENTRAPPED. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. ON EVALUATION OF THE RETURNED DEVICE, THE FLEXOR WAS MEASURED AS 39.3CM, WHICH IS WITHIN SPECIFICATION OF 40CM +1.3CM -0.8CM. WITH THE HANDLE FULLY WITHDRAWN, THE FLEXOR MEASURED 44.4CM. THE FLEXOR WAS SEPARATED, WITH SOME UNCOILING DAMAGE. THE COIL WAS CUT, AND THE FLEXOR WAS REMOVED. THERE WAS NO PUSHER RING OBSERVED ON THE INNER PEEK CATHETER. WITH THE HANDLE FULLY OPEN, THE INNER PEEK MEASURED 35.5CM. THE INNER PEEK WAS BROKEN PROXIMAL TO THE PUSHER RING. SOME MATERIAL BECAME DISLODGED. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FLEXOR WAS FOUND TO BE SEPARATED. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE SEVERELY TORTUOUS PATIENT ANATOMY. THE PATIENT HAD PREVIOUSLY BEEN TREATED WITH SURGERY TO REMOVE THE DUODENUM. THE PATIENT ANATOMY COULD HAVE APPLIED HIGH FORCES TO THE COMPLAINT DEVICE DURING DEPLOYMENT. THESE FORCES COULD HAVE CAUSED THE STENT AND DELIVERY SHEATH MARKER RING BECOMING ENTRAPPED, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE SHEATHS SEPARATING. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL ZIB6 (ZILVER BILIARY) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1246814. ACCORDING TO THE INITIAL REPORTER, IT IS UNCLEAR IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: ZILVER 635 SELF-EXPANDING BILIARY STENT WAS ADVANCED OVER THE WIRE GUIDE AND IT WAS ATTEMPTED TO DEPLOY. BUT AFTER THE STENT WAS DEPLOYED 3CM, THE USER COULD NOT DEPLOY THE STENT ANYMORE (THE HANDLE COULD NOT BE MANIPULATED). SO, HE REPLACED THE WIRE GUIDE FROM TERUMO/RADIFOCUS TO COIL WIRE GUIDE, HOWEVER THE SITUATION DID NOT CHANGE. SINCE THE DEVICE COULD NOT LEAVE IN THE PATIENTS' BODY, HE PULLED THE OUTER SHEATH (INTRODUCER CATHETER) TO DEPLOY THE STENT. THEN, THE OUTER SHEATH GOT SEPARATED AND REMAINED IN THE PATIENTS¿ BODY. SINCE SEPARATED PART OF THE OUTER SHEATH CONSTRICTED THE STENT, IT WAS DIFFICULT TO REMOVE THE INNER SHEATH. WHEN THE USER PULLED THE INNER SHEATH, THE TIP OF THE INNER SHEATH GOT SEPARATED AND REMAINED IN THE PLACED STENT. THE PROCEDURE ENDED AT THIS MOMENT, BUT THE FUTURE PROCEDURE IS UNDER CONSIDERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464566 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | 10827002314860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |