ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2017-00392
- Event Type
- Malfunction
- Date Received
- September 12, 2017
- Date of Event
- April 14, 2017
- Report Date
- September 20, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002248905
- PMA / PMN Number
- P100022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
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. THE ZIV6-35-125-6-80-PTX DEVICE OF LOT NUMBER C970391 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR INVESTIGATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT IS KNOWN THAT THE PATIENT HAD THE FOLLOWING PRE-EXISTING CONDITIONS: THIS 62-YEAR-OLD MALE PRESENTED AT THE TIME OF ENROLLMENT WITH A HISTORY OF HYPERTENSION AND SMOKING (CURRENT). THE LESION MORPHOLOGY REVEALED A TASC I AND TASC II TYPE B LESION WITH NO CALCIFICATION OR THROMBUS. THERE WAS A PREVIOUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE STUDY LESION. THE PRE-PROCEDURAL ABI WAS 0.64 FOR THE STUDY LEG. THERE WAS NO INFLOW TRACT STENOSIS GREATER THAN 50% AND THREE PATENT RUNOFF VESSELS. BASELINE ANGIOGRAPHIC MEASUREMENTS REVEALED A PROXIMAL REFERENCE VESSEL DIAMETER (RVD) OF 5.0 MM, A DISTAL RVD OF 5.0 MM, AND 100% DIAMETER STENOSIS. THE LESION LENGTH WAS 100.0 MM. IMAGING REVIEW IS CURRENTLY PENDING FOR THIS PATIENT. THE INVESTIGATION WILL BE UPDATED FOLLOWING THE RECEIPT OF THE IMAGING REVIEW. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER ADDITIONAL INFORMATION RECEIVED FROM THE ORIGINATOR, THE PHYSICIAN DID NOT RELATE THE WORSENING CLAUDICATION/REST PAIN OR OCCLUSION/RESTENOSIS TO THE STUDY STENT. THEREFORE NO ADDITIONAL COMPLAINTS WERE REPORTED FOR THIS PATIENT. AS IMAGING REVIEW IS CURRENTLY PENDING, A ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION WILL BE UPDATED FOLLOWING THE RECEIPT OF THE IMAGING REVIEW. IT MAY BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE, STENT STRUT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. 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 THE LOT NUMBER C970391. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C970391. THERE WAS NO INTERVENTION PERFORMED AGAINST THE STENT FRACTURE. THE PATIENT REMAINS IN THE STUDY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR ANY POTENTIAL EMERGING TRENDS.
(B)(4), PATIENT (B)(6) ¿ STENT FRACTURE. ON (B)(6) 2014, THE PATIENT RECEIVED TWO 6 MM X 80 MM ZILVER PTX STUDY STENTS IN THE RIGHT DISTAL SFA. THE PATIENT UNDERWENT PRE-DILATATION OF THE STUDY LESION WITH TWO INFLATIONS OF A 5.0 MM X 300 MM BALLOON AT 14 ATM FOR 120 SECONDS. TWO 6.0 MM X 80 MM (LOT #¿S C970391) WERE PLACED OVERLAPPING ONE ANOTHER IN THE RIGHT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT FOR EACH STENT DEVICE DEPLOYMENT WAS EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6.0 MM X 300 MM BALLOON AT 10 ATM FOR 120 SECONDS, AND ONE INFLATION OF A 6.0 MM X 80 MM BALLOON AT 10 ATM FOR 120 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE PHYSICIAN, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVD WAS 5.0 MM. THE POST-PROCEDURAL ABI WAS 1.10 FOR THE STUDY LEG. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING PLAVIX AND ASPIRIN. ON (B)(6) 2015, THE TWELVE MONTH FOLLOW-UP CLINICAL ASSESSMENT, ULTRASOUND, AND X-RAY WERE PERFORMED. THE ABI WAS 1.18 AND THE RUTHERFORD CLASSIFICATION WAS ZERO FOR THE STUDY LEG. THE ULTRASOUND REVEALED PATENCY PROXIMAL, WITHIN, AND DISTAL TO THE STUDY LESION. THE X-RAY REVEALED NO EVIDENCE OF FRACTURE. CORE LAB CONCURRED WITH THE SITE¿S FINDINGS. THE PATIENT CONTINUED TO TAKE PLAVIX AND ASPIRIN. ON (B)(6) 2015, THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION DUE TO WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAPHY REVEALED THAT THE STENTS WERE OCCLUDED. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE RESIDUAL STENOSIS AFTER ALL TREATMENTS WAS < 50%. ON (B)(6) 2015, UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION DUE TO WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAPHY REVEALED THAT THE STENTS WERE OCCLUDED. TREATMENT WAS A RIGHT FEMORAL TO ABOVE THE KNEE POPLITEAL ARTERY BYPASS. ON (B)(6) 2015, THE PATIENT UNDERWENT A THROMBOLYSIS OF THEIR OCCLUDED RIGHT FEMORAL-POPLITEAL BYPASS GRAFT AND STOPPED TAKING PLAVIX AND BEGAN TAKING COUMADIN. ON (B)(6) 2016, THE TWO YEAR FOLLOW-UP CLINICAL ASSESSMENT WAS PERFORMED. THE ABI WAS 1.12 AND THE RUTHERFORD CLASSIFICATION WAS ZERO FOR THE STUDY LEG. THE ULTRASOUND WAS NOT DONE. ON (B)(6) 2017, THE THREE YEAR FOLLOW-UP CLINICAL ASSESSMENT AND X-RAY WERE PERFORMED. THE ULTRASOUND WAS NOT DONE. THE ABI WAS 1.10 AND THE (B)(6) CLASSIFICATION WAS ZERO FOR THE STUDY LEG. THE X-RAY REVEALED NO EVIDENCE OF FRACTURE. CORE LAB ANALYSIS OF THE X-RAY REVEALED EVIDENCE OF A TYPE I PROXIMAL FRACTURE IN STUDY STENT TWO. STUDY STENT ONE HAD NO EVIDENCE OF FRACTURE. CORE LAB NOTED: ¿STENT DEFECT COMPATIBLE WITH FRACTURE IN PROXIMAL MARGIN OF STENT - AREA OF OVERLAP WITH A NON-STUDY STENT.¿
(B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. THE ZIV6-35-125-6-80-PTX DEVICE OF LOT NUMBER C970391 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR INVESTIGATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT IS KNOWN THAT THE PATIENT HAD THE FOLLOWING PRE-EXISTING CONDITIONS: THIS (B)(6) YEAR-OLD MALE PRESENTED AT THE TIME OF ENROLLMENT WITH A HISTORY OF HYPERTENSION AND SMOKING (CURRENT). THE LESION MORPHOLOGY REVEALED A TASC I AND TASC II TYPE B LESION WITH NO CALCIFICATION OR THROMBUS. THERE WAS A PREVIOUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE STUDY LESION. THE PRE-PROCEDURAL ABI WAS 0.64 FOR THE STUDY LEG. THERE WAS NO INFLOW TRACT STENOSIS GREATER THAN 50% AND THREE PATENT RUNOFF VESSELS. BASELINE ANGIOGRAPHIC MEASUREMENTS REVEALED A PROXIMAL REFERENCE VESSEL DIAMETER (RVD) OF 5.0 MM, A DISTAL RVD OF 5.0 MM, AND 100% DIAMETER STENOSIS. THE LESION LENGTH WAS 100.0 MM. AS PER ADDITIONAL INFORMATION RECEIVED FROM THE ORIGINATOR, THE PHYSICIAN DID NOT RELATE THE WORSENING CLAUDICATION/REST PAIN OR OCCLUSION/RESTENOSIS TO THE STUDY STENT. THEREFORE NO ADDITIONAL COMPLAINTS WERE REPORTED FOR THIS PATIENT. 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: THE STUDY LESION WAS A MID-RIGHT SFA OCCLUSION FLANKED BY MODERATE TO SEVERE DIFFUSE STENOSIS EXTENDING PROXIMALLY TO THE SFA ORIGIN AND DISTALLY TO THE POPLITEAL SFA JUNCTION. RUNOFF WAS TWO VESSELS IN TO THE FOOT. THE PROXIMAL STUDY STENT WAS OVER EXPANDED TO 7MM DURING THE FIRST SECONDARY INTERVENTION. THE OVEREXPANSION WAS THE RESULT OF AN INCOMPRESSIBLE MASS OF ATHEROMA/NEOINTIMAL HYPERPLASIA INSIDE THE STENT. WHEN DISPLACED PERIPHERALLY BY THE BALLOON, THE MASS OVEREXPANDED THE STENT. A LINEAR PLAQUE DISSECTION ALSO OCCURRED AT THE STENT'S SUPERIOR MARGIN. THIS PROVIDED A WEAKENED AREA OF VESSEL WALL FOR THE NOW FRACTURED STENT TO FURTHER FLARE INTO. THE SFA WAS OCCLUDED ON A FOLLOW UP ULTRASOUND PERFORMED 11 DAYS AFTER THE FIRST SECONDARY INTERVENTION. THIS ULTRASOUND DEMONSTRATED A SEGMENT OF STENT FLARING BEYOND THE VESSEL WALL IDENTICAL TO THE APPEARANCE ON FOLLOW UP X-RAY TWO YEARS LATER. THE X-RAYS DEMONSTRATE FRACTURE OF THE RIGHT SIDE OF THE PROXIMAL STENT CELL SECTION THAT ALLOWED IT TO FLARE INTO THE DISSECTION, ACHIEVING A DIAMETER OF 8.9MM. THE FRACTURE WAS CONSISTENT WITH A TYPE I FRACTURE. STENT PATENCY WAS CHALLENGED AFTER IMPLANTATION BY DIFFUSE INFLOW LIMITATION, PRIMARILY FROM LINEAR DISSECTION OF THE SFA PROXIMAL TO THE STENTS, WITH GREATER THAN 30% RESIDUAL STENOSIS AND DIFFUSELY DISEASED RIGHT EXTERNAL ILIAC ARTERY (EIA). THE EIA ESTIMATED DIAMETER BASED OFF THE FLUSH CATHETER WAS BETWEEN 4 MM TO 5MM. BASED ON BALLOON DEFORMATION, SIGNIFICANT NEOINTIMAL HYPERPLASIA WAS PRESENT AT THE FIRST SECONDARY INTERVENTION AT THE SUPERIOR END OF THE PROXIMAL STENT, THE INFERIOR END OF THE PROXIMAL STENT JUST SUPERIOR TO THE OVERLAP, AND AT THE INFERIOR END OF THE DISTAL STENT. BECAUSE THE OCCLUSION AFTER THE FIRST SECONDARY INTERVENTION OCCURRED ONLY 11 DAYS LATER, IT WAS THROMBOTIC IN NATURE. IMPRESSION: A TYPE I FRACTURE OF THE PROXIMAL STENT SUPERIOR CELL SECTION WAS CAUSED BY OVEREXPANSION DURING THE FIRST SECONDARY INTERVENTION. INCOMPRESSIBLE ATHEROMA/NEOINTIMAL HYPERPLASIA ADDED TO THE BALLOON DIAMETER FRACTURING THE RIGHT SIDE OF THE SUPERIOR CELL SECTION. AN ASSOCIATED DISSECTION ALLOWED THE STENT END FLARE AND WAS EVIDENT ON ULTRASOUND 11 DAYS POST AS WELL AS ON THE FOLLOW UP X-RAY TWO YEARS LATER. THE FRACTURE WAS CLINICALLY IRRELEVANT TO THE SECOND OCCLUSIVE EVENT AND WILL NOT AFFECT THE BYPASS. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE OBSERVED. INFLOW WAS LIMITED BY DIFFUSE RIGHT EIA STENOSIS AND POST ANGIOPLASTY PLAQUE RECOIL AND DISSECTION OF THE PROXIMAL SFA. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE INFLOW LIMITATIONS WERE NOT OPTIMIZED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE STUDY STENTS DEVELOPED FOCAL AREAS OF SIGNIFICANT NEOINTIMAL HYPERPLASIA DURING THE FIRST SECONDARY INTERVENTION DURING BALLOON ANGIOPLASTY. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. BASED ON THE IMAGING REVIEW THE CUSTOMER COMPLAINT IS CONFIRMED, AS A TYPE I FRACTURE OF THE PROXIMAL STENT WAS APPARENT ON THE IMAGES. IT WAS STATED BY THE INDEPENDENT REVIEWER THAT THE ROOT CAUSE OF THE STENT FRACTURE WAS AS A RESULT OF OVEREXPANSION DURING THE FIRST SECONDARY INTERVENTION. THE OVEREXPANSION WAS THE RESULT OF AN INCOMPRESSIBLE MASS OF ATHEROMA/NEOINTIMAL HYPERPLASIA INSIDE THE STENT. WHEN DISPLACED PERIPHERALLY BY THE BALLOON, THE MASS OVEREXPANDED THE STENT. A LINEAR PLAQUE DISSECTION ALSO OCCURRED AT THE STENT'S SUPERIOR MARGIN. THIS PROVIDED A WEAKENED AREA OF VESSEL WALL FOR THE NOW FRACTURED STENT TO FURTHER FLARE INTO. IT MAY BE NOTED THAT THERE ARE NO COMPLAINTS CURRENTLY OPEN FOR THE WORSENING CLAUDICATION/REST PAIN OR OCCLUSION/RESTENOSIS AS OUTLINED ABOVE. THE PHYSICIAN DID NOT RELATE THE WORSENING CLAUDICATION/REST PAIN OR OCCLUSION/RESTENOSIS TO THE STUDY STENT; THEREFORE NO COMPLAINTS WERE GENERATED BASED ON THIS. IT MAY BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE, STENT STRUT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. 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 THE LOT NUMBER C970391. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C970391. THERE WAS NO INTERVENTION PERFORMED AGAINST THE STENT FRACTURE. THE PATIENT REMAINS IN THE STUDY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR ANY POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL REPORT DETAILS: (B)(6) STENT FRACTURE. ON (B)(6) 2014, THE PATIENT RECEIVED TWO 6 MM X 80 MM ZILVER PTX STUDY STENTS IN THE RIGHT DISTAL SFA. THE PATIENT UNDERWENT PRE-DILATATION OF THE STUDY LESION WITH TWO INFLATIONS OF A 5.0 MM X 300 MM BALLOON AT 14 ATM FOR 120 SECONDS. TWO 6.0 MM X 80 MM (LOT #S C970391) WERE PLACED OVERLAPPING ONE ANOTHER IN THE RIGHT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT FOR EACH STENT DEVICE DEPLOYMENT WAS EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6.0 MM X 300 MM BALLOON AT 10 ATM FOR 120 SECONDS, AND ONE INFLATION OF A 6.0 MM X 80 MM BALLOON AT 10 ATM FOR 120 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE PHYSICIAN, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVD WAS 5.0 MM. THE POST-PROCEDURAL ABI WAS 1.10 FOR THE STUDY LEG. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING PLAVIX AND ASPIRIN. ON (B)(6) 2015, THE TWELVE MONTH FOLLOW-UP CLINICAL ASSESSMENT, ULTRASOUND, AND X-RAY WERE PERFORMED. THE ABI WAS 1.18 AND THE RUTHERFORD CLASSIFICATION WAS ZERO FOR THE STUDY LEG. THE ULTRASOUND REVEALED PATENCY PROXIMAL, WITHIN, AND DISTAL TO THE STUDY LESION. THE X-RAY REVEALED NO EVIDENCE OF FRACTURE. (B)(6) CONCURRED WITH THE SITES FINDINGS. THE PATIENT CONTINUED TO TAKE PLAVIX AND ASPIRIN. ON (B)(6) 2015, THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION DUE TO WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAPHY REVEALED THAT THE STENTS WERE OCCLUDED. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE RESIDUAL STENOSIS AFTER ALL TREATMENTS WAS < 50%. ON (B)(6) 2015, UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION DUE TO WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAPHY REVEALED THAT THE STENTS WERE OCCLUDED. TREATMENT WAS A RIGHT FEMORAL TO ABOVE THE KNEE POPLITEAL ARTERY BYPASS. ON (B)(6) 2015, THE PATIENT UNDERWENT A THROMBOLYSIS OF THEIR OCCLUDED RIGHT FEMORAL-POPLITEAL BYPASS GRAFT AND STOPPED TAKING PLAVIX AND BEGAN TAKING COUMADIN. ON (B)(6) 2016, THE TWO YEAR FOLLOW-UP CLINICAL ASSESSMENT WAS PERFORMED. THE ABI WAS 1.12 AND THE RUTHERFORD CLASSIFICATION WAS ZERO FOR THE STUDY LEG. THE ULTRASOUND WAS NOT DONE. ON (B)(6) 2017, THE THREE YEAR FOLLOW-UP CLINICAL ASSESSMENT AND X-RAY WERE PERFORMED. THE ULTRASOUND WAS NOT DONE. THE ABI WAS 1.10 AND THE RUTHERFORD CLASSIFICATION WAS ZERO FOR THE STUDY LEG. THE X-RAY REVEALED NO EVIDENCE OF FRACTURE. (B)(6) ANALYSIS OF THE X-RAY REVEALED EVIDENCE OF A TYPE I PROXIMAL FRACTURE IN STUDY STENT TWO. STUDY STENT ONE HAD NO EVIDENCE OF FRACTURE. (B)(6) NOTED: STENT DEFECT COMPATIBLE WITH FRACTURE IN PROXIMAL MARGIN OF STENT - AREA OF OVERLAP WITH A NON-STUDY STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638642 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G24890 | 10827002248905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |