ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2017-00506
- Event Type
- Malfunction
- Date Received
- November 3, 2017
- Date of Event
- October 4, 2017
- Report Date
- December 29, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002384634
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) # P100022/S014 THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION.. THE ZISV6-35-125-6-40-PTX DEVICE OF LOT NUMBER C1393173 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, THERE ARE NO IMAGES OF THE PROCEDURE AVAILABLE. THE CUSTOMER STATED THAT THERE IS NO INFORMATION TO SUGGEST OR CONFIRM THAT THE DEPLOYMENT DIFFICULTIES WERE RELATED TO THE THROMBOSIS. THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.035¿ DIAMETER, STORQ WIRE GUIDE. THERE WAS NO ELONGATION OF THE STENT REPORTED. THE TARGET LOCATION WAS NOT CALCIFIED OR TORTUOUS, BUT THE ILIAC ARTERIES HAD KISSING STENTS. IT IS NOT KNOWN IF PREDILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. THE STENT ENTIRELY DEPLOYED IN THE PATIENT, BY WITHDRAWING THE DEVICE OVER THE WIRE GUIDE. THE CUSTOMER DOES NOT BELIEVE THAT THE DEPLOYMENT DIFFICULTIES CONTRIBUTED TO THE THROMBOSIS OF THE RIGHT ILIAC STENT. ON EVALUATION OF THE DEVICE, A KINK WAS OBSERVED IN THE STABILITY SHEATH (SS) AT 15.5CM FROM THE OVER MOULD. THE RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). A SECOND KINK WAS OBSERVED IN THE STABILITY SHEATH AT 7.9CM FROM THE OVER MOULD. THE ENGINEERS WERE UNABLE TO MOVE THE DELIVERY SYSTEM CATHETERS OVER EACH OTHER, DUE TO THE KINKS IN THE STABILITY SHEATH, AND FURTHER DAMAGED THE STABILITY SHEATH AT THE KINKS IN THE ATTEMPT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RETRACTION WIRE WAS FOUND TO BE SEPARATED FROM THE STENT RETRACTION SHEATH (SRS). POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE KINKS IN THE STABILITY SHEATH. THE KINKS IN THE SHEATH COULD HAVE BEEN CAUSED DURING ADVANCEMENT OR DUE TO DEVICE HANDLING. THE KINKS COULD HAVE APPLIED FORCES TO THE RETRACTION WIRE/STENT RETRACTION SHEATH BOND DURING DEPLOYMENT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE RETRACTION WIRE SEPARATING FROM THE STENT RETRACTION SHEATH. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PRODUCT INSTRUCTIONS FOR USE. 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. 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 C1393173. ACCORDING TO INFORMATION PROVIDED, THE PATIENT RECEIVED TREATMENT FOR THROMBOSIS, BUT THERE IS NO EVIDENCE TO SUGGEST THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS DEVICE OR OCCURRENCE. THE STENT WAS FULLY DEPLOYED IN THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED 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. INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS ABOUT 20% DEPLOYED OR ABOUT 3 TO 4 CELLS AND THE WHEEL ON THE HANDLE STOPPED RETRACTING THE SHEATH. IT WAS NOT UNSHEATHING THE STENT." THE RIGHT ILIAC ABBOT STENT THROMBOSED OFF AND THE SFA STENTS DID NOT. THE PATIENT WAS LOADED WITH 300 MILLIGRAMS OF PLAVIX. EVENT DESCRIPTION / UPDATED INFO PROVIDED BY DM ON 11OCT2017: "ACCESS WAS GAINED IN LEFT GROIN FOR A RLE INTERVENTION. MICROPUNCTURE WAS USED FOR ACCESS. BENTSON WIRE INSERTED THROUGH MPIS, SWAPPED OUT FOR 5FR SHEATH. DIAGNOSTIC CATH INSERTED OVER THE WIRE INTO DISTAL AORTA. WIRE REMOVED AND AORTOGRAM PERFORM. KISSING ILIAC STENTS (ABBOTT OMNILINK) CONFIRMED AT THE BIFURCATION. WIRE ADVANCED CONTRATERALLY TO LESION IN MID SFA. CATHETER ADVANCED. WIRE SWAPPED OUT FOR STIFFER WIRE. CATHETER AND 5FR SHEATH REMOVED. 6FR ANSEL INSERTED AND CROSSES BIFURCATION. DILATOR REMOVED AND 6FRX120MM ZILVER PTX INSERTED TO COVER DISTAL LESION. ZPTX DEPLOYED. CATHETER REMOVED. 6FRX40MM ZILVER PTX INSERTED TO COVER PROXIMAL PORTION OF LESION. SAFETY BUTTON PUSHED, APPROXIMATELY 20% OR 3-4 CELLS OF STENT UNSHEATHED WHEN THE WHEEL STOPPED WORKING. THE STENT WAS NO LONGER UNSHEATHING. THE DELIVERY HANDLE WHEEL COULD SPIN WITHOUT UNSHEATHING. PHYSICIAN ATTEMPTED TO ¿WALK¿ THE CATHETER BACK OVER-THE-WIRE AND THE STENT CAME OUT OF THE CATHETER. THE PLACEMENT OF THE STENT WAS AS INTENDED BUT THE DELIVERY OF WAS FAR FROM NORMAL. THE PATIENT WAS NOT ON PLAVIX AND WAS LOADED WITH 300MG. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT WAS ADMITTED ONE DAY LATER TO A (B)(6) FACILITY FOR A THROMBOSED RIGHT ILIAC STENT. PATIENT HAD TO SPEND THE NIGHT FOR THROMBOLYSIS. I HAVE NO FURTHER INFORMATION ON THE SUCCESS OF THE THROMBOLYSIS OR PATIENT. THE PHYSICIAN DOES NOT BELIEVE THE FAILURE OF THE DELIVERY HANDLE CONTRIBUTED TO THE THROMBOSING OF THE ABBOTT STENT. THERE ARE MULTIPLE REASONS THE ABBOTT STENT MAY HAVE THROMBOSED.
MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE 'THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT''. AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS ABOUT 20% DEPLOYED OR ABOUT 3 TO 4 CELLS AND THE WHEEL ON THE HANDLE STOPPED RETRACTING THE SHEATH. IT WAS NOT UNSHEATHING THE STENT." THE RIGHT ILIAC ABBOT STENT THROMBOSED OFF AND THE SFA STENTS DID NOT. THE PATIENT WAS LOADED WITH 300 MILLIGRAMS OF PLAVIX. EVENT DESCRIPTION / UPDATED INFO PROVIDED BY DM ON (B)(6) 2017: "ACCESS WAS GAINED IN LEFT GROIN FOR A RLE INTERVENTION. MICROPUNCTURE WAS USED FOR ACCESS. BENTSON WIRE INSERTED THROUGH MPIS, SWAPPED OUT FOR 5FR SHEATH. DIAGNOSTIC CATH INSERTED OVER THE WIRE INTO DISTAL AORTA. WIRE REMOVED AND AORTOGRAM PERFORM. KISSING ILIAC STENTS (ABBOTT OMNILINK) CONFIRMED AT THE BIFURCATION. WIRE ADVANCED CONTRATERALLY TO LESION IN MID SFA. CATHETER ADVANCED. WIRE SWAPPED OUT FOR STIFFER WIRE. CATHETER AND 5FR SHEATH REMOVED. 6FR ANSEL INSERTED AND CROSSES BIFURCATION. DILATOR REMOVED AND 6FRX120MM ZILVER PTX INSERTED TO COVER DISTAL LESION. ZPTX DEPLOYED. CATHETER REMOVED. 6FRX40MM ZILVER PTX INSERTED TO COVER PROXIMAL PORTION OF LESION. SAFETY BUTTON PUSHED, APPROXIMATELY 20% OR 3-4 CELLS OF STENT UNSHEATHED WHEN THE WHEEL STOPPED WORKING. THE STENT WAS NO LONGER UNSHEATHING. THE DELIVERY HANDLE WHEEL COULD SPIN WITHOUT UNSHEATHING. PHYSICIAN ATTEMPTED TO ¿WALK¿ THE CATHETER BACK OVER-THE-WIRE AND THE STENT CAME OUT OF THE CATHETER. THE PLACEMENT OF THE STENT WAS AS INTENDED BUT THE DELIVERY OF WAS FAR FROM NORMAL. THE PATIENT WAS NOT ON PLAVIX AND WAS LOADED WITH 300MG. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT WAS ADMITTED ONE DAY LATER TO A (B)(6) FACILITY FOR A THROMBOSED RIGHT ILIAC STENT. PATIENT HAD TO SPEND THE NIGHT FOR THROMBOLYSIS. I HAVE NO FURTHER INFORMATION ON THE SUCCESS OF THE THROMBOLYSIS OR PATIENT.
(B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # P100022/S014. THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE DEVICE HAS BEEN RETURNED AND INVESTIGATION CONCLUSIONS ARE PENDING. A FOLLOW UP WILL BE SUBMITTED IN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
(B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # P100022/S014. THE ZISV6-35-125-6-40-PTX DEVICE OF LOT NUMBER C1393173 INVOLVED IN THIS COMPLAINT HAS NOT YET BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED. THE INVESTIGATION WILL BE UPDATED IF THE DEVICE IS RETURNED AND EVALUATED AT A LATER DATE. FROM CUSTOMER TESTIMONY, THERE ARE NO IMAGES OF THE PROCEDURE AVAILABLE. THE CUSTOMER STATED THAT THERE IS NO INFORMATION TO SUGGEST OR CONFIRM THAT THE DEPLOYMENT DIFFICULTIES WERE RELATED TO THE THROMBOSIS. THE COMPLAINT DEVICE WAS ADVANCED OVER A 0.035¿ DIAMETER, STORQ WIRE GUIDE. THERE WAS NO ELONGATION OF THE STENT REPORTED. THE TARGET LOCATION WAS NOT CALCIFIED OR TORTUOUS, BUT THE ILIAC ARTERIES HAD KISSING STENTS. IT IS NOT KNOWN IF PREDILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT. THE STENT ENTIRELY DEPLOYED IN THE PATIENT, BY WITHDRAWING THE DEVICE OVER THE WIRE GUIDE. THE CUSTOMER DOES NOT BELIEVE THAT THE DEPLOYMENT DIFFICULTIES CONTRIBUTED TO THE THROMBOSIS OF THE RIGHT ILIAC STENT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. POSSIBLE CAUSE FOR THIS OCCURRENCE COULD BE A DIFFICULT ANATOMY. A DIFFICULT ANATOMY COULD HAVE CREATED RESISTANCE DURING DEPLOYMENT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE FAILURE TO DEPLOY THE STENT. HOWEVER, IT MAY BE NOTED THAT THE PATIENT'S ANATOMY WAS NOT DESCRIBED AS SEVERELY TORTUOUS OR CALCIFIED. HOWEVER, AS THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED, AND THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PRODUCT INSTRUCTIONS FOR USE. 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. 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 C1393173. IT MAY BE NOTED THAT THE FAILURE MODE OF "DEPLOYMENT DIFFICULT" HAS BEEN PROVISIONALLY ASSIGNED. THE FINAL FAILURE MODE WILL BE CONFIRMED FOLLOWING DEVICE RETURN AND EVALUATION. ACCORDING TO INFORMATION PROVIDED, THE PATIENT RECEIVED TREATMENT FOR THROMBOSIS, BUT THERE IS NO EVIDENCE TO SUGGEST THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS DEVICE OR OCCURRENCE. THE STENT WAS FULLY DEPLOYED IN THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE DEVICE HAS BEEN RETURNED AND INVESTIGATION CONCLUSIONS ARE PENDING. A FOLLOW UP WILL BE SUBMITTED IN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS; MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE 'THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT''. AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS ABOUT 20% DEPLOYED OR ABOUT 3 TO 4 CELLS AND THE WHEEL ON THE HANDLE STOPPED RETRACTING THE SHEATH. IT WAS NOT UNSHEATHING THE STENT." THE RIGHT ILIAC ABBOT STENT THROMBOSED OFF AND THE SFA STENTS DID NOT. THE PATIENT WAS LOADED WITH 300 MILLIGRAMS OF PLAVIX. EVENT DESCRIPTION / UPDATED INFO PROVIDED BY DM ON 11OCT2017: "ACCESS WAS GAINED IN LEFT GROIN FOR A RLE INTERVENTION. MICROPUNCTURE WAS USED FOR ACCESS. BENTSON WIRE INSERTED THROUGH MPIS, SWAPPED OUT FOR 5FR SHEATH. DIAGNOSTIC CATH INSERTED OVER THE WIRE INTO DISTAL AORTA. WIRE REMOVED AND AORTOGRAM PERFORM. KISSING ILIAC STENTS (ABBOTT OMNILINK) CONFIRMED AT THE BIFURCATION. WIRE ADVANCED CONTRATERALLY TO LESION IN MID SFA. CATHETER ADVANCED. WIRE SWAPPED OUT FOR STIFFER WIRE. CATHETER AND 5FR SHEATH REMOVED. 6FR ANSEL INSERTED AND CROSSES BIFURCATION. DILATOR REMOVED AND 6FRX120MM ZILVER PTX INSERTED TO COVER DISTAL LESION. ZPTX DEPLOYED. CATHETER REMOVED. 6FRX40MM ZILVER PTX INSERTED TO COVER PROXIMAL PORTION OF LESION. SAFETY BUTTON PUSHED, APPROXIMATELY 20% OR 3-4 CELLS OF STENT UNSHEATHED WHEN THE WHEEL STOPPED WORKING. THE STENT WAS NO LONGER UNSHEATHING. THE DELIVERY HANDLE WHEEL COULD SPIN WITHOUT UNSHEATHING. PHYSICIAN ATTEMPTED TO ¿WALK¿ THE CATHETER BACK OVER-THE-WIRE AND THE STENT CAME OUT OF THE CATHETER. THE PLACEMENT OF THE STENT WAS AS INTENDED BUT THE DELIVERY OF WAS FAR FROM NORMAL. THE PATIENT WAS NOT ON PLAVIX AND WAS LOADED WITH 300MG. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT WAS ADMITTED ONE DAY LATER TO A (B)(6) FACILITY FOR A THROMBOSED RIGHT ILIAC STENT. PATIENT HAD TO SPEND THE NIGHT FOR THROMBOLYSIS. I HAVE NO FURTHER INFORMATION ON THE SUCCESS OF THE THROMBOLYSIS OR PATIENT. THE PHYSICIAN DOES NOT BELIEVE THE FAILURE OF THE DELIVERY HANDLE CONTRIBUTED TO THE THROMBOSING OF THE ABBOTT STENT. THERE ARE MULTIPLE REASONS THE ABBOTT STENT MAY HAVE THROMBOSED.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE UPDATE AND CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS; MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE 'THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT''. AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS ABOUT 20% DEPLOYED OR ABOUT 3 TO 4 CELLS AND THE WHEEL ON THE HANDLE STOPPED RETRACTING THE SHEATH. IT WAS NOT UNSHEATHING THE STENT." THE RIGHT ILIAC ABBOT STENT THROMBOSED OFF AND THE SFA STENTS DID NOT. THE PATIENT WAS LOADED WITH 300 MILLIGRAMS OF PLAVIX. EVENT DESCRIPTION / UPDATED INFO PROVIDED BY (B)(6) ON 11OCT2017: "ACCESS WAS GAINED IN LEFT GROIN FOR A RLE INTERVENTION. MICROPUNCTURE WAS USED FOR ACCESS. BENTSON WIRE INSERTED THROUGH MPIS, SWAPPED OUT FOR 5FR SHEATH. DIAGNOSTIC CATH INSERTED OVER THE WIRE INTO DISTAL AORTA. WIRE REMOVED AND AORTOGRAM PERFORM. KISSING ILIAC STENTS (ABBOTT (B)(4)) CONFIRMED AT THE BIFURCATION. WIRE ADVANCED CONTRATERALLY TO LESION IN MID SFA. CATHETER ADVANCED. WIRE SWAPPED OUT FOR STIFFER WIRE. CATHETER AND 5FR SHEATH REMOVED. 6FR ANSEL INSERTED AND CROSSES BIFURCATION. DILATOR REMOVED AND 6FRX120MM ZILVER PTX INSERTED TO COVER DISTAL LESION. ZPTX DEPLOYED. CATHETER REMOVED. 6FRX40MM ZILVER PTX INSERTED TO COVER PROXIMAL PORTION OF LESION. SAFETY BUTTON PUSHED, APPROXIMATELY 20% OR 3-4 CELLS OF STENT UNSHEATHED WHEN THE WHEEL STOPPED WORKING. THE STENT WAS NO LONGER UNSHEATHING. THE DELIVERY HANDLE WHEEL COULD SPIN WITHOUT UNSHEATHING. PHYSICIAN ATTEMPTED TO ¿WALK¿ THE CATHETER BACK OVER-THE-WIRE AND THE STENT CAME OUT OF THE CATHETER. THE PLACEMENT OF THE STENT WAS AS INTENDED BUT THE DELIVERY OF WAS FAR FROM NORMAL. THE PATIENT WAS NOT ON PLAVIX AND WAS LOADED WITH 300MG. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT WAS ADMITTED ONE DAY LATER TO A SAN FRANCISCO FACILITY FOR A THROMBOSED RIGHT ILIAC STENT. PATIENT HAD TO SPEND THE NIGHT FOR THROMBOLYSIS. I HAVE NO FURTHER INFORMATION ON THE SUCCESS OF THE THROMBOLYSIS OR PATIENT. THE PHYSICIAN DOES NOT BELIEVE THE FAILURE OF THE DELIVERY HANDLE CONTRIBUTED TO THE THROMBOSING OF THE ABBOTT STENT. THERE ARE MULTIPLE REASONS THE ABBOTT STENT MAY HAVE THROMBOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 781042 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38463 | 10827002384634 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |