ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2016-00097
- Event Type
- Injury
- Date Received
- April 20, 2016
- Date of Event
- February 9, 2016
- Report Date
- May 17, 2016
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002352770
- PMA / PMN Number
- P100022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- NURSE
Narratives
PMA/510(K)#: P100022/S014. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION (THE STENT REMAINS IMPLANTED IN THE PATIENT). WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO SUPPORT THE COMPLAINT INVESTIGATION. HOWEVER TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED. ZISV6-35-125-5.0-120-PTX OF LOT NUMBER C1176321 WAS IMPLANTED IN THE PATIENT TO SECURE A LARGE CALCIFIC PLAQUE IN THE PATIENTS LEFT SFA. THE STENT WAS PLACED SUCCESSFULLY, HOWEVER THE MOBILE PLAQUE WAS COMPRESSING THE DISTAL END OF THE STENT. THE USER THEN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM, HOWEVER THE DELIVERY SYSTEM WOULD NOT PULL BACK THROUGH THE DEPLOYED STENT. THE INFORMATION ABOVE SUGGESTS THE DISTAL END OF THE STENT WAS COMPRESSED DUE TO THE PATIENT`S CONDITION '..LARGE CALCIFIC PLAQUE..'. AS THE DISTAL END OF THE STENT WAS COMPRESSED, THE USER WAS UNABLE TO REMOVE THE DELIVERY SYSTEM AS THE TIP OF THE DELIVERY SYSTEM GOT CAUGHT IN THE COMPRESSED SECTION OF THE STENT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THESE WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: THE LESION WAS AN OCCLUSION INVOLVING THE DISTAL HALF OF THE SFA TERMINATING AT THE ADDUCTOR CANAL. THE PROXIMAL SFA AND SFA FROM THE ADDUCTOR CANAL TO THE POPLITEAL ARTERY AT THE PATELLA WERE COLLAPSED WITH ADDITIONAL STENOSIS PROXIMAL THE OCCLUSION. AT THE PATELLA, INCREASED PRESSURE FROM A COLLATERAL GENICULATE ARTERY RESTORED THE PA DIAMETER TO NEAR NORMAL. RUNOFF WAS LIMITED BY DIFFUSE SEVERE DISTAL PERONEAL AND ANTERIOR TIBIAL ARTERY STENOSIS FROM MID TO DISTAL CALF AND A MODERATE TO SEVERE DISTAL POSTERIOR TIBIAL ARTERY STENOSIS. THE ANKLE AND FOOT RUNOFF IMAGING WAS NOT PROVIDED. THE OCCLUSION WAS CROSSED AND WITH THE PATH OF THE WIRE NOT DEVIATING FROM THE EXPECTED POSITION OF THE OCCLUDED SFA LUMEN. THE STENOSIS JUST PROXIMAL THE OCCLUSION WAS RESISTANT TO ANGIOPLASTY AS EVIDENT AS A FOCAL BALLOON WAIST WHILE THE REST OF THE BALLOON WAS FULLY EXPANDED. THIS STENOSIS MAY HAVE BEEN THE ORIGIN OF THE PLAQUE MENTIONED IN THE COMPLAINT REPORT. THE CALCIFICATION MENTIONED IN THE COMPLAINT REPORT IS NOT EVIDENT ON THE PROVIDED IMAGING. POST ANGIOPLASTY ANGIOGRAPHY DEMONSTRATED A PERSISTENT FILLING DEFECT AT THE PROXIMAL OCCLUSION.THE SUPERIOR AND INFERIOR MARGINS OF THE OCCLUSION HAD A MENISCAL APPEARANCE INDICATIVE OF AN EMBOLISM RATHER THAN DISSECTED PLAQUE. ADDITIONALLY THE ARTERY SEGMENT WHICH HAD CREATED THE BALLOON WAIST ON THE PRECEDING ANGIOPLASTY NOW APPEARED NORMAL. THESE IMAGING FINDINGS ARE CONSISTENT WITH THE REPORT NARRATIVE OF PLAQUE EMBOLIZATION EXCEPT THAT NO CALCIFICATION WAS EVIDENT. THE STENT WAS DEPLOYED HOWEVER THE DISTAL END WAS UNABLE TO EXPAND EVEN ENOUGH TO ALLOW THE DELIVERY SYSTEM TIP TO PASS THROUGH. A SECOND CATHETER WAS PLACED AND A WIRE PASSED THROUGH THE DISTAL STENT. PASSING A LOW PROFILE ANGIOPLASTY BALLOON THROUGH THE STENT WAS UNSUCCESSFUL. THE FINAL IMAGING SHOWS THAT THE DISTAL STENT WAS PULLED IN TWO BY ATTEMPTS TO FORCE EITHER THE ANGIOPLASTY BALLOON OR THE DELIVERY SYSTEM THROUGH THE DISTAL STENT END. THE DISTAL STENT REMAINED COMPRESSED DESPITE ITS FORCED ADVANCEMENT. IMPRESSION: THE IMAGING IS CONSISTENT WITH THE REPORT NARRATIVE OF PLAQUE EMBOLISM PREVENTING DISTAL STENT EXPANSION EXCEPT THAT NO CALCIFICATION WAS OBSERVED. IT IS POSSIBLE THAT THE PLAQUE WAS ASSUMED CALCIFIED BECAUSE IT SEEMED INCOMPRESSIBLE. HAD PLAQUE CALCIFICATION BEEN VISIBLE, ITS PRESUMED DISPLACEMENT BY THE STENT DELIVERY SYSTEM ADVANCEMENT AND CONSEQUENT STENT MALPOSITION RELATIVE TO THE PLAQUE WOULD HAVE BEEN EVIDENT BEFORE STENT DEPLOYMENT. ANGIOGRAPHY PRIOR TO STENT DEPLOYMENT WOULD HAVE REVEALED THE RELATIVE STENT PLAQUE MALPOSITION. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. AN INCOMPRESSIBLE PLAQUE EMBOLISM WAS PRESENT. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. ALTHOUGH THIS WAS AN UNUSUAL SITUATION, THE STENT WAS DEPLOYED BEFORE CORRECT POSITION RELATIVE TO THE PLAQUE WAS VERIFIED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. BECAUSE THE STENT DID NOT EXPAND, THE DELIVERY SYSTEM COULD NOT BE RETRIEVED. THERE IS NO EVIDENCE OF STENT DEFECT. CAUSE OF ANY ADVERSE EFFECTS WAS OBSERVED. THE INCOMPRESSIBLE PLAQUE WAS THE PRIMARY REASON THE INTERVENTION FAILED AND THE PATIENT WENT TO FEM-POP BYPASS. IF A LOW PROFILE BALLOON COULD NOT BE ADVANCED PAST THE PLAQUE, IT IS DOUBTFUL THAT A DURABLE RESULT WOULD HAVE BEEN ACHIEVED WITH SUCCESSFUL DEPLOYMENT OF ANY AVAILABLE SELF-EXPANDING STENT. THE PLAQUE WOULD HAVE LIKELY QUICKLY COMPRESSED THE STENT TO OCCLUSION. BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS THE IMAGES DEMONSTRATED STENT COMPRESSION OF THE ZILVER PTX STENT. THE IMAGE REVIEW ABOVE CORRESPONDS WITH THE COMPLAINT DESCRIPTION. POST DEPLOYMENT OF THE COMPLAINT DEVICE THE DISTAL END OF THE STENT WAS COMPRESSED BY PLAQUE ¿..PLAQUE EMBOLISM PREVENTING DISTAL STENT EXPANSION¿ / ¿AN INCOMPRESSIBLE PLAQUE EMBOLISM WAS PRESENT..¿ AS THE DISTAL END OF THE STENT DID NOT EXPAND, THE USER WAS UNABLE TO RETRACT THE DELIVERY SYSTEM. BASED ON THE ABOVE ¿THE INCOMPRESSIBLE PLAQUE WAS THE PRIMARY REASON THE INTERVENTION FAILED AND THE PATIENT WENT TO FEM-POP BYPASS. IF A LOW PROFILE BALLOON COULD NOT BE ADVANCED PAST THE PLAQUE, IT IS DOUBTFUL THAT A DURABLE RESULT WOULD HAVE BEEN ACHIEVED WITH SUCCESSFUL DEPLOYMENT OF ANY AVAILABLE SELF-EXPANDING STENT. THE PLAQUE WOULD HAVE LIKELY QUICKLY COMPRESSED THE STENT TO OCCLUSION¿. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY SETTING A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
PMA/510(K)#: P100022/S014. PROBLEM STATEMENT: WHEN DEPLOYING STENT SOME CALCIUM MOVED DOWN THE VESSEL, EXTERNAL COMPRESSION AT DISTAL STENT, WHEN RETRACTING INNER DELIVERY CATHETER TIP WAS STUCK & COULD NOT REMOVE THE DELIVERY PART OF THE STENT. "AS PER COMPLAINT FORM": LEFT SFA ANGIOPLASTY VIA L ANTEGRADE APPROACH. THE LESION WAS PRE-DILATED WITH AN EV3 EVERCROSS 5X20MM BALLOON. IT APPEARED THAT A LARGE CALCIFIC PLAQUE VISIBLE DURING PRE-DILATION WAS MOBILE AND MOVING DOWN THE VESSEL. TO SECURE THE PLAQUE THEY PLACED A ZILVER PTX (DETAILED). AT THE TIME OF DEPLOYMENT THEY FELT THAT THE STENT WAS ACROSS THE MOBILE PLAQUE BUT THE STENT SYSTEM MAY HAVE BEEN PUSHING THE PLAQUE FURTHER DOWN THE VESSEL. POTENTIALLY, THIS MOBILE PLAQUE WAS COMPRESSING THE DISTAL END OF THE STENT. THE STENT WAS FULLY UNSHEATHED, BUT THE INNER STENT DELIVERY TIP WOULD NOT PULL BACK THROUGH THE DEPLOYED STENT. IMAGES APPEAR TO SHOW THE DISTAL TIP OF THE STENT, BEING HEAVILY EXTERNALLY COMPRESSED. DEVICE EVALUATION: THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION (THE STENT REMAINS IMPLANTED IN THE PATIENT). WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ZISV6-35-125-5.0-120-PTX OF LOT NUMBER C1176321 WAS IMPLANTED IN THE PATIENT TO SECURE A LARGE CALCIFIC PLAQUE IN THE PATIENTS LEFT SFA. THE STENT WAS PLACED SUCCESSFULLY, HOWEVER THE MOBILE PLAQUE WAS COMPRESSING THE DISTAL END OF THE STENT. THE USER THEN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM, HOWEVER THE DELIVERY SYSTEM WOULD NOT PULL BACK THROUGH THE DEPLOYED STENT. THE INFORMATION ABOVE SUGGESTS THE DISTAL END OF THE STENT WAS COMPRESSED DUE TO THE PATIENT`S CONDITION '..LARGE CALCIFIC PLAQUE..'. AS THE DISTAL END OF THE STENT WAS COMPRESSED, THE USER WAS UNABLE TO REMOVE THE DELIVERY SYSTEM AS THE TIP OF THE DELIVERY SYSTEM GOT CAUGHT IN THE COMPRESSED SECTION OF THE STENT. ACCORDING TO ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN: ¿THE PATIENT WENT TO THEATRE WITH THE FULL INTENT OF REMOVING DELIVERY SYSTEM AND THE STENT AS THE STENT TIP LOOKED TO BE HEAVILY COMPRESSED. WHEN THE SURGERY WAS PERFORMED THERE WAS A VERY HARD CALCIFIC MATTER PRESSING ON THE 'NOSE CONE' WHICH CAME OUT AT THE SAME TIME. THEY UNDERSTOOD THIS TO BE WHY THE DELIVERY SYSTEM WOULDN'T RELEASE FROM THE STENT. THE STENT WAS REMOVED FROM THE PATIENT. THE PATIENT HAS RECENTLY BEEN REVIEWED AND IS DOING VERY WELL POST SURGERY¿ IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THESE WERE REVIEWED AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER. FINDINGS: THE LESION WAS AN OCCLUSION INVOLVING THE DISTAL HALF OF THE SFA TERMINATING AT THE ADDUCTOR CANAL. THE PROXIMAL SFA AND SFA FROM THE ADDUCTOR CANAL TO THE POPLITEAL ARTERY AT THE PATELLA WERE COLLAPSED WITH ADDITIONAL STENOSIS PROXIMAL THE OCCLUSION. AT THE PATELLA, INCREASED PRESSURE FROM A COLLATERAL GENICULATE ARTERY RESTORED THE PA DIAMETER TO NEAR NORMAL. RUNOFF WAS LIMITED BY DIFFUSE SEVERE DISTAL PERONEAL AND ANTERIOR TIBIAL ARTERY STENOSIS FROM MID TO DISTAL CALF AND A MODERATE TO SEVERE DISTAL POSTERIOR TIBIAL ARTERY STENOSIS. THE ANKLE AND FOOT RUNOFF IMAGING WAS NOT PROVIDED. THE OCCLUSION WAS CROSSED AND WITH THE PATH OF THE WIRE NOT DEVIATING FROM THE EXPECTED POSITION OF THE OCCLUDED SFA LUMEN. THE STENOSIS JUST PROXIMAL THE OCCLUSION WAS RESISTANT TO ANGIOPLASTY AS EVIDENT AS A FOCAL BALLOON WAIST WHILE THE REST OF THE BALLOON WAS FULLY EXPANDED. THIS STENOSIS MAY HAVE BEEN THE ORIGIN OF THE PLAQUE MENTIONED IN THE COMPLAINT REPORT. THE CALCIFICATION MENTIONED IN THE COMPLAINT REPORT IS NOT EVIDENT ON THE PROVIDED IMAGING. POST ANGIOPLASTY ANGIOGRAPHY DEMONSTRATED A PERSISTENT FILLING DEFECT AT THE PROXIMAL OCCLUSION. THE SUPERIOR AND INFERIOR MARGINS OF THE OCCLUSION HAD A MENISCAL APPEARANCE INDICATIVE OF AN EMBOLISM RATHER THAN DISSECTED PLAQUE. ADDITIONALLY THE ARTERY SEGMENT WHICH HAD CREATED THE BALLOON WAIST ON THE PRECEDING ANGIOPLASTY NOW APPEARED NORMAL. THESE IMAGING FINDINGS ARE CONSISTENT WITH THE REPORT NARRATIVE OF PLAQUE EMBOLIZATION EXCEPT THAT NO CALCIFICATION WAS EVIDENT. THE STENT WAS DEPLOYED HOWEVER THE DISTAL END WAS UNABLE TO EXPAND EVEN ENOUGH TO ALLOW THE DELIVERY SYSTEM TIP TO PASS THROUGH. A SECOND CATHETER WAS PLACED AND A WIRE PASSED THROUGH THE DISTAL STENT. PASSING A LOW PROFILE ANGIOPLASTY BALLOON THROUGH THE STENT WAS UNSUCCESSFUL. THE FINAL IMAGING SHOWS THAT THE DISTAL STENT WAS PULLED IN TWO BY ATTEMPTS TO FORCE EITHER THE ANGIOPLASTY BALLOON OR THE DELIVERY SYSTEM THROUGH THE DISTAL STENT END. THE DISTAL STENT REMAINED COMPRESSED DESPITE ITS FORCED ADVANCEMENT. IMPRESSION: THE IMAGING IS CONSISTENT WITH THE REPORT NARRATIVE OF PLAQUE EMBOLISM PREVENTING DISTAL STENT EXPANSION EXCEPT THAT NO CALCIFICATION WAS OBSERVED. IT IS POSSIBLE THAT THE PLAQUE WAS ASSUMED CALCIFIED BECAUSE IT SEEMED INCOMPRESSIBLE. HAD PLAQUE CALCIFICATION BEEN VISIBLE, ITS PRESUMED DISPLACEMENT BY THE STENT DELIVERY SYSTEM ADVANCEMENT AND CONSEQUENT STENT MALPOSITION RELATIVE TO THE PLAQUE WOULD HAVE BEEN EVIDENT BEFORE STENT DEPLOYMENT. ANGIOGRAPHY PRIOR TO STENT DEPLOYMENT WOULD HAVE REVEALED THE RELATIVE STENT PLAQUE MALPOSITION. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. AN INCOMPRESSIBLE PLAQUE EMBOLISM WAS PRESENT. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. ALTHOUGH THIS WAS AN UNUSUAL SITUATION, THE STENT WAS DEPLOYED BEFORE CORRECT POSITION RELATIVE TO THE PLAQUE WAS VERIFIED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. BECAUSE THE STENT DID NOT EXPAND, THE DELIVERY SYSTEM COULD NOT BE RETRIEVED. THERE IS NO EVIDENCE OF STENT DEFECT. CAUSE OF ANY ADVERSE EFFECTS WAS OBSERVED. THE INCOMPRESSIBLE PLAQUE WAS THE PRIMARY REASON THE INTERVENTION FAILED AND THE PATIENT WENT TO FEM-POP BYPASS. IF A LOW PROFILE BALLOON COULD NOT BE ADVANCED PAST THE PLAQUE, IT IS DOUBTFUL THAT A DURABLE RESULT WOULD HAVE BEEN ACHIEVED WITH SUCCESSFUL DEPLOYMENT OF ANY AVAILABLE SELF-EXPANDING STENT. THE PLAQUE WOULD HAVE LIKELY QUICKLY COMPRESSED THE STENT TO OCCLUSION. BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS THE IMAGES DEMONSTRATED STENT COMPRESSION OF THE ZILVER PTX STENT. THE IMAGE REVIEW ABOVE CORRESPONDS WITH THE COMPLAINT DESCRIPTION. POST DEPLOYMENT OF THE COMPLAINT DEVICE THE DISTAL END OF THE STENT WAS COMPRESSED BY PLAQUE ¿..PLAQUE EMBOLISM PREVENTING DISTAL STENT EXPANSION¿ / ¿AN INCOMPRESSIBLE PLAQUE EMBOLISM WAS PRESENT..¿ AS THE DISTAL END OF THE STENT DID NOT EXPAND, THE USER WAS UNABLE TO RETRACT THE DELIVERY SYSTEM. BASED ON THE ABOVE ¿THE INCOMPRESSIBLE PLAQUE WAS THE PRIMARY REASON THE INTERVENTION FAILED AND THE PATIENT WENT TO FEM-POP BYPASS. IF A LOW PROFILE BALLOON COULD NOT BE ADVANCED PAST THE PLAQUE, IT IS DOUBTFUL THAT A DURABLE RESULT WOULD HAVE BEEN ACHIEVED WITH SUCCESSFUL DEPLOYMENT OF ANY AVAILABLE SELF-EXPANDING STENT. THE PLAQUE WOULD HAVE LIKELY QUICKLY COMPRESSED THE STENT TO OCCLUSION¿. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY SETTING A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. SUMMARY: BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS THE IMAGES DEMONSTRATED STENT COMPRESSION OF THE ZILVER PTX STENT. BASED ON THE COMPLAINT INFORMATION AND IMAGING REVIEW FINDINGS, THE DISTAL END OF THE STENT WAS COMPRESSED DUE TO THE PATIENT`S CONDITION '..LARGE CALCIFIC PLAQUE..'. THEREFORE THE USER WAS UNABLE TO REMOVE THE DELIVERY SYSTEM AS THE TIP OF THE DELIVERY SYSTEM GOT CAUGHT IN THE COMPRESSED SECTION OF THE STENT. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY SETTING A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. THE PHYSICIAN REMOVED THE COMPLAINT DEVICE (DELIVERY SYSTEM AND STENT) FROM THE PATIENT. THE PATIENT HAS RECENTLY BEEN REVIEWED AND IS DOING VERY WELL POST SURGERY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
PMA/510(K)#: P100022/S014. THE INVESTIGATION INTO THIS EVENT IS CURRENTLY STILL IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
THIS FOLLOW UP REPORT IS BEING SENT DUE TO THE CONCLUSION OF THE INVESTIGATION. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: WHEN DEPLOYING THE ZILVER PTX STENT SOME CALCIUM MOVED DOWN THE VESSEL, EXTERNAL COMPRESSION AT DISTAL STENT, WHEN RETRACTING INNER DELIVERY CATHETER TIP WAS STUCK & COULD NOT REMOVE THE DELIVERY PART OF THE STENT. LEFT SFA ANGIOPLASTY VIA L ANTEGRADE APPROACH.THE LESION WAS PRE-DILATED WITH AN EV3 EVERCROSS 5X20MM BALLOON. IT APPEARED THAT A LARGE CALCIFIC PLAQUE VISIBLE DURING PRE-DILATION WAS MOBILE AND MOVING DOWN THE VESSEL. TO SECURE THE PLAQUE THEY PLACED A ZILVER PTX. AT THE TIME OF DEPLOYMENT THEY FELT THAT THE STENT WAS ACROSS THE MOBILE PLAQUE BUT THE STENT SYSTEM MAY HAVE BEEN PUSHING THE PLAQUE FURTHER DOWN THE VESSEL. POTENTIALLY,THIS MOBILE PLAQUE WAS COMPRESSING THE DISTAL END OF THE STENT. THE STENT WAS FULLY UNSHEATHED, BUT THE INNER STENT DELIVERY TIP WOULD NOT PULL BACK THROUGH THE DEPLOYED STENT. IMAGES APPEAR TO SHOW THE DISTAL TIP OF THE STENT, BEING HEAVILY EXTERNALLY COMPRESSED. IT WAS SUGGESTED BY THE HOSPITAL PARTY THAT THIS COULD HAVE HAPPENED TO ANY STENT DUE TO THE EXTERNAL COMPRESSION OF CALCIUM ON THE STENT.
THIS FOLLOW UP REPORT IS BEING SENT DUE TO THE RECEIPT OF ADDITIONAL INFORMATION AND CONSEQUENT UPDATE TO THE INVESTIGATION DETAILS. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: WHEN DEPLOYING THE ZILVER PTX STENT SOME CALCIUM MOVED DOWN THE VESSEL, EXTERNAL COMPRESSION AT DISTAL STENT, WHEN RETRACTING INNER DELIVERY CATHETER TIP WAS STUCK & COULD NOT REMOVE THE DELIVERY PART OF THE STENT. LEFT SFA ANGIOPLASTY VIA L ANTEGRADE APPROACH. THE LESION WAS PRE-DILATED WITH AN EV3 EVERCROSS 5X20MM BALLOON. IT APPEARED THAT A LARGE CALCIFIC PLAQUE VISIBLE DURING PRE-DILATION WAS MOBILE AND MOVING DOWN THE VESSEL. TO SECURE THE PLAQUE THEY PLACED A ZILVER PTX. AT THE TIME OF DEPLOYMENT THEY FELT THAT THE STENT WAS ACROSS THE MOBILE PLAQUE BUT THE STENT SYSTEM MAY HAVE BEEN PUSHING THE PLAQUE FURTHER DOWN THE VESSEL. POTENTIALLY,THIS MOBILE PLAQUE WAS COMPRESSING THE DISTAL END OF THE STENT. THE STENT WAS FULLY UNSHEATHED, BUT THE INNER STENT DELIVERY TIP WOULD NOT PULL BACK THROUGH THE DEPLOYED STENT. IMAGES APPEAR TO SHOW THE DISTAL TIP OF THE STENT, BEING HEAVILY EXTERNALLY COMPRESSED. IT WAS SUGGESTED BY THE HOSPITAL PARTY THAT THIS COULD HAVE HAPPENED TO ANY STENT DUE TO THE EXTERNAL COMPRESSION OF CALCIUM ON THE STENT. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: THE PATIENT WENT TO THEATRE WITH THE FULL INTENT OF REMOVING THE DELIVERY SYSTEM AND THE STENT AS THE STENT TIP LOOKED TO BE HEAVILY COMPRESSED. WHEN THE SURGERY WAS PERFORMED THERE WAS A VERY HARD CALCIFIC MATTER PRESSING ON THE 'NOSE CONE' WHICH CAME OUT AT THE SAME TIME. THEY UNDERSTOOD THIS TO BE WHY THE DELIVERY SYSTEM WOULDN'T RELEASE FROM THE STENT. THE STENT WAS REMOVED FROM THE PATIENT. THE PATIENT HAS RECENTLY BEEN REVIEWED AND IS DOING VERY WELL POST SURGERY.
WHEN DEPLOYING THE ZILVER PTX STENT SOME CALCIUM MOVED DOWN THE VESSEL, EXTERNAL COMPRESSION AT DISTAL STENT, WHEN RETRACTING INNER DELIVERY CATHETER TIP WAS STUCK & COULD NOT REMOVE THE DELIVERY PART OF THE STENT. LEFT SFA ANGIOPLASTY VIA L ANTEGRADE APPROACH. THE LESION WAS PRE-DILATED WITH AN EV3 EVERCROSS 5X20MM BALLOON. IT APPEARED THAT A LARGE CALCIFIC PLAQUE VISIBLE DURING PRE-DILATION WAS MOBILE AND MOVING DOWN THE VESSEL. TO SECURE THE PLAQUE THEY PLACED A ZILVER PTX. AT THE TIME OF DEPLOYMENT THEY FELT THAT THE STENT WAS ACROSS THE MOBILE PLAQUE BUT THE STENT SYSTEM MAY HAVE BEEN PUSHING THE PLAQUE FURTHER DOWN THE VESSEL. POTENTIALLY,THIS MOBILE PLAQUE WAS COMPRESSING THE DISTAL END OF THE STENT. THE STENT WAS FULLY UNSHEATHED, BUT THE INNER STENT DELIVERY TIP WOULD NOT PULL BACK THROUGH THE DEPLOYED STENT. IMAGES APPEAR TO SHOW THE DISTAL TIP OF THE STENT, BEING HEAVILY EXTERNALLY COMPRESSED. IT WAS SUGGESTED BY THE HOSPITAL PARTY THAT THIS COULD HAVE HAPPENED TO ANY STENT DUE TO THE EXTERNAL COMPRESSION OF CALCIUM ON THE STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245512 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | 10827002352770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |