ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2016-00023
- Event Type
- Injury
- Date Received
- February 2, 2016
- Date of Event
- December 18, 2015
- Report Date
- March 14, 2016
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- PMA / PMN Number
- P100022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(6) THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C970392 WAS IMPLANTED IN THE PATIENT, THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: ¿FINDINGS: INTERVENTION ANGIOGRAPHY, 1 YEAR FOLLOW UP ULTRASOUND AND X-RAYS, AND 20 MONTH POST IMPLANTATION SECONDARY ANGIOGRAPHY IS PROVIDED ALONG WITH THE COMPLAINT REPORT. THE TARGET LESION WAS A FOCAL SEVERE DISTAL LEFT SFA STENOSIS. THIS LESION WAS SURROUNDED BY EXTENSIVE ATHEROSCLEROTIC DISEASE INVOLVING THE LEFT COMMON FEMORAL ARTERY (CFA), THE PROXIMAL AND MID SFA AND POPLITEAL ARTERY (PA). THE CALF VESSELS WERE SMALL BUT WITHOUT FOCAL STENOSIS. THE ILIAC ARTERIES WERE CHRONICALLY OCCLUDED. AN AORTA UNI-ILIAC BYPASS PROVIDED BLOOD SUPPLY TO THE LEFT CFA WITH A LEFT TO RIGHT FEM-FEM SUPPLYING THE RIGHT LEG. A SMA STENT AND THE RIGHT RENAL ARTERY WERE SEVERELY STENOTIC. THE TARGET LESION WAS IMPROVED TO 50% WITH ANGIOPLASTY. IT WAS SUBSEQUENTLY STENTED WITH A MINIMAL DIAMETER OF 4.7MM ACHIEVED THROUGH THE STENT. THE SFA ORIGIN STENOSIS WAS IMPROVED TO 3MM WITH 5MM ANGIOPLASTY. THE PA STENOSIS WAS DIFFUSE AND NOT TREATED. THE PA WAS 2.8MM IN DIAMETER. AT ONE YEAR ON ULTRASOUND SIGNIFICANT PEAK SYSTOLIC VELOCITY ELEVATION CONSISTENT WITH 50-99% STENOSIS WAS PRESENT AT THE LEFT AORTO UNI-ILIAC LEFT CFA ANASTOMOSIS AND IN THE MID LEFT SFA PROXIMAL THE STENT. THE STENT WAS WITHOUT STENOSIS. NO STENT FRACTURE WAS EVIDENT AT ONE YEAR X-RAY. AT 20 MONTHS, THE SFA WAS OCCLUDED AT A SEVERE ORIGIN STENOSIS THROUGH THE SFA STENT AND INTO THE PROXIMAL PA. AFTER ANGIOPLASTY, A DISSECTED PLAQUE AT THE LEFT SFA ORIGIN CAUSING SIGNIFICANT RESIDUAL STENOSIS WAS EVIDENCE OF SIGNIFICANT STENOSIS PROGRESSION SINCE IMPLANTATION. NO OTHER RESIDUAL LESIONS WERE PRESENT EXCEPT FOR A SMALL PARTIALLY OCCLUSIVE POPLITEAL EMBOLISM WHICH WAS ELIMINATED BUT LIKELY NOT WITHOUT DISTAL EMBOLIZATION AS THE CALF RUNOFF WAS SIGNIFICANTLY DIMINISHED ON THE FINAL PROVIDED ANGIOGRAM. NO STENOSIS WAS PRESENT INSIDE THE SFA STENT. IMPRESSION: 6 MONTHS PRIOR TO THE LEFT SFA OCCLUSION, SIGNIFICANT LEFT ILIAC BYPASS LIMB AND MID SFA STENOSIS WERE PRESENT PROXIMAL A NORMAL STENT. AT OCCLUSION, A SEVERE SFA ORIGIN STENOSIS WAS EVIDENT AFTER THROMBOLYSIS AND ANGIOPLASTY. THE STENT WAS WITHOUT SIGNIFICANT NEOINTIMAL HYPERPLASIA. CONSEQUENTLY, THE OCCLUSION WAS THE RESULT OF PROGRESSIVE INFLOW LIMITATION AND NOT IN-STENT STENOSIS. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT¿S ANATOMY WERE OBSERVED. THE INFLOW WAS LIMITED AT THE LEFT SFA ORIGIN AND OUTFLOW LIMITED AT THE BELOW KNEE POPLITEAL ARTERY. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. THE OVERALL BURDEN OF ATHEROSCLEROTIC DISEASE WAS SEVERE. THE PROGRESSIVE SFA LEFT ILIAC BYPASS LIMB ANASTOMOSIS, SFA ORIGIN, AND MID SFA STENOSIS WERE RESPONSIBLE FOR SFA AND STENT THROMBOSIS. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CAUSE OF ANY ADVERSE EFFECTS WERE OBSERVED. THE DISTAL RUNOFF WAS SIGNIFICANTLY MORE LIMITED ON THE FINAL IMAGING CONSISTENT WITH DISTAL EMBOLIZATION.¿ THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS IMAGING REVEALED OCCLUSION THROUGH THE STENTED REGION. ACCORDING TO THE IMAGING REVIEW, THE SFA WAS OCCLUDED AT A SEVERE ORIGIN STENOSIS THROUGH THE SFA STENT. HOWEVER, THE STENT WAS WITHOUT SIGNIFICANT NEOINTIMAL HYPERPLASIA. IN ADDITION, PROGRESSIVE SFA LEFT BYPASS LIMB ANASTOMOSIS, SFA ORIGIN STENOSIS AND MID SFA STENOSIS WERE RESPONSIBLE FOR SFA AND STENT THROMBOSIS. BASED ON THE IMAGING REVIEW, THE OCCLUSION WAS THE RESULT OF PROGRESSIVE INFLOW LIMITATION. HOWEVER, THE REVIEWER ALSO REFERS TO DISTAL EMBOLIZATION AS THE CAUSE OF THE ADVERSE EFFECTS OBSERVED. IT CAN BE NOTED THAT THE PHYSICIAN INDICATED THAT PRE-EXISTING VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THE EVENT. IT CAN BE NOTED THAT SIGNIFICANT FINDINGS RELATIVE TO THE DEVICE DESIGN OR PERFORMANCE WERE NOT OBSERVED. BASED ON THE ABOVE, IT CAN BE STATED THAT IT IS UNLIKELY THAT THE REPORTED OCCLUSION COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION. THE MOST LIKELY CAUSE OF THIS EVENT WAS THE PATIENT¿S CONDITION. HOWEVER, A DEFINITIVE ROOT CAUSE OF THIS OCCURRENCE CANNOT BE DETERMINED. IT MAY BE NOTED THAT AS PER INSTRUCTION FOR USE, EMBOLISM, ARTERIAL THROMBOSIS AND RESTENOSIS OF THE STENTED ARTERY ARE KNOWN POTENTIAL ADVERSE EVENTS 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. ACCORDING TO INFORMATION PROVIDED BALLOON ANGIOPLASTY WAS CARRIED OUT. NO ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
(B)(6). THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C970392 WAS IMPLANTED IN THE PATIENT, THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ACCORDING TO INFORMATION PROVIDED THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING CORONARY ARTERY DISEASE, HYPERTENSION, MYOCARDIAL INFARCTION AND A HISTORY OF TOBACCO USE. IN ADDITION, THE PHYSICIAN INDICATED THAT PRE-EXISTING VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THE EVENT. RESTENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PTA AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO (OR AMPLIFIES) THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. IT CAN BE THEREFORE STATED THAT IT IS VERY UNLIKELY THAT THE REPORTED RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT AS PER INSTRUCTION FOR USE RESTENOSIS OF THE STENTED ARTERY 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. ACCORDING TO INFORMATION PROVIDED BALLOON ANGIOPLASTY WAS CARRIED OUT. NO ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
(B)(6). THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C970392 WAS IMPLANTED IN THE PATIENT, THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION AND WERE REVIEWED AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: ¿FINDINGS: INTERVENTION ANGIOGRAPHY, 1 YEAR FOLLOW UP ULTRASOUND AND X-RAYS, AND 20 MONTH POST IMPLANTATION SECONDARY ANGIOGRAPHY IS PROVIDED ALONG WITH THE COMPLAINT REPORT. THE TARGET LESION WAS A FOCAL SEVERE DISTAL LEFT SFA STENOSIS. THIS LESION WAS SURROUNDED BY EXTENSIVE ATHEROSCLEROTIC DISEASE INVOLVING THE LEFT COMMON FEMORAL ARTERY (CFA), THE PROXIMAL AND MID SFA AND POPLITEAL ARTERY (PA). THE CALF VESSELS WERE SMALL BUT WITHOUT FOCAL STENOSIS. THE ILIAC ARTERIES WERE CHRONICALLY OCCLUDED. AN AORTA UNI-ILIAC BYPASS PROVIDED BLOOD SUPPLY TO THE LEFT CFA WITH A LEFT TO RIGHT FEM-FEM SUPPLYING THE RIGHT LEG. A SMA STENT AND THE RIGHT RENAL ARTERY WERE SEVERELY STENOTIC. THE TARGET LESION WAS IMPROVED TO 50% WITH ANGIOPLASTY. IT WAS SUBSEQUENTLY STENTED WITH A MINIMAL DIAMETER OF 4.7MM ACHIEVED THROUGH THE STENT. THE SFA ORIGIN STENOSIS WAS IMPROVED TO 3MM WITH 5MM ANGIOPLASTY. THE PA STENOSIS WAS DIFFUSE AND NOT TREATED. THE PA WAS 2.8MM IN DIAMETER. AT ONE YEAR ON ULTRASOUND SIGNIFICANT PEAK SYSTOLIC VELOCITY ELEVATION CONSISTENT WITH 50-99% STENOSIS WAS PRESENT AT THE LEFT AORTO UNI-ILIAC LEFT CFA ANASTOMOSIS AND IN THE MID LEFT SFA PROXIMAL THE STENT. THE STENT WAS WITHOUT STENOSIS. NO STENT FRACTURE WAS EVIDENT AT ONE YEAR X-RAY. AT 20 MONTHS, THE SFA WAS OCCLUDED AT A SEVERE ORIGIN STENOSIS THROUGH THE SFA STENT AND INTO THE PROXIMAL PA. AFTER ANGIOPLASTY, A DISSECTED PLAQUE AT THE LEFT SFA ORIGIN CAUSING SIGNIFICANT RESIDUAL STENOSIS WAS EVIDENCE OF SIGNIFICANT STENOSIS PROGRESSION SINCE IMPLANTATION. NO OTHER RESIDUAL LESIONS WERE PRESENT EXCEPT FOR A SMALL PARTIALLY OCCLUSIVE POPLITEAL EMBOLISM WHICH WAS ELIMINATED BUT LIKELY NOT WITHOUT DISTAL EMBOLIZATION AS THE CALF RUNOFF WAS SIGNIFICANTLY DIMINISHED ON THE FINAL PROVIDED ANGIOGRAM. NO STENOSIS WAS PRESENT INSIDE THE SFA STENT. IMPRESSION: SIX (6) MONTHS PRIOR TO THE LEFT SFA OCCLUSION, SIGNIFICANT LEFT ILIAC BYPASS LIMB AND MID SFA STENOSIS WERE PRESENT PROXIMAL A NORMAL STENT. AT OCCLUSION, A SEVERE SFA ORIGIN STENOSIS WAS EVIDENT AFTER THROMBOLYSIS AND ANGIOPLASTY. THE STENT WAS WITHOUT SIGNIFICANT NEOINTIMAL HYPERPLASIA. CONSEQUENTLY, THE OCCLUSION WAS THE RESULT OF PROGRESSIVE INFLOW LIMITATION AND NOT IN-STENT STENOSIS. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT¿S ANATOMY WERE OBSERVED. THE INFLOW WAS LIMITED AT THE LEFT SFA ORIGIN AND OUTFLOW LIMITED AT THE BELOW KNEE POPLITEAL ARTERY. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. THE OVERALL BURDEN OF ATHEROSCLEROTIC DISEASE WAS SEVERE. THE PROGRESSIVE SFA LEFT ILIAC BYPASS LIMB ANASTOMOSIS, SFA ORIGIN, AND MID SFA STENOSIS WERE RESPONSIBLE FOR SFA AND STENT THROMBOSIS. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CAUSE OF ANY ADVERSE EFFECTS WERE OBSERVED. THE DISTAL RUNOFF WAS SIGNIFICANTLY MORE LIMITED ON THE FINAL IMAGING CONSISTENT WITH DISTAL EMBOLIZATION.¿ THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS IMAGING REVEALED OCCLUSION THROUGH THE STENTED REGION. ACCORDING TO THE IMAGING REVIEW, THE SFA WAS OCCLUDED AT A SEVERE ORIGIN STENOSIS THROUGH THE SFA STENT. HOWEVER, THE STENT WAS WITHOUT SIGNIFICANT NEOINTIMAL HYPERPLASIA. IN ADDITION, PROGRESSIVE SFA LEFT BYPASS LIMB ANASTOMOSIS, SFA ORIGIN STENOSIS AND MID SFA STENOSIS WERE RESPONSIBLE FOR SFA AND STENT THROMBOSIS. BASED ON THE IMAGING REVIEW, THE OCCLUSION WAS THE RESULT OF PROGRESSIVE INFLOW LIMITATION. HOWEVER, THE REVIEWER ALSO REFERS TO DISTAL EMBOLIZATION AS THE CAUSE OF THE ADVERSE EFFECTS OBSERVED. IT CAN BE NOTED THAT THE PHYSICIAN INDICATED THAT PRE-EXISTING VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THE EVENT. CLARIFICATION REGARDING THE CAUSE OF THIS EVENT AND THE PRESENCE OF RESTENOSIS AND/OR THROMBOSIS WAS REQUESTED. IT WAS CONFIRMED THAT NO RESTENOSIS WAS PRESENT, HOWEVER THROMBOSIS WAS PRESENT. IT WAS ALSO CONFIRMED THAT THE REPORTED OCCLUSION WAS DUE TO PROGRESSIVE INFLOW LIMITATION WHICH IN TURN CAUSED THROMBOSIS. IT CAN BE NOTED THAT SIGNIFICANT FINDINGS RELATIVE TO THE DEVICE DESIGN OR PERFORMANCE WERE NOT OBSERVED. BASED ON THE ABOVE, IT CAN BE STATED THAT IT IS UNLIKELY THAT THE REPORTED OCCLUSION COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION. THE MOST LIKELY CAUSE OF THIS EVENT WAS THE PATIENT¿S CONDITION. HOWEVER, A DEFINITIVE ROOT CAUSE OF THIS OCCURRENCE CANNOT BE DETERMINED. IT MAY BE NOTED THAT AS PER INSTRUCTION FOR USE, EMBOLISM, ARTERIAL THROMBOSIS AND RESTENOSIS OF THE STENTED ARTERY ARE KNOWN POTENTIAL ADVERSE EVENTS 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. ACCORDING TO INFORMATION PROVIDED BALLOON ANGIOPLASTY WAS CARRIED OUT. NO ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL EVENT DESCRIPTION SUBMITTED AS FOLLOWS: PROTOCOL (B)(4), PT. (B)(6), OCCLUSION/RESTENOSIS REQUIRING INTERVENTION - POSSIBLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED VIA ULTRASOUND WITH AN OCCLUSION/RESTENOSIS OF THE LEFT DISTAL SFA OCCURRING WITHIN THE STUDY LESION. CLINICAL SIGNS AND SYMPTOMS INCLUDED NEW ONSET CLAUDICATION AND NUMBNESS. PRE-INTERVENTION MEASUREMENTS REVEALED THE RIGHT AND LEFT ABIS WERE 0.94 AND 0.54, RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND FOUR, RESPECTIVELY. ON (B)(6) 2016, THE PATIENT UNDERWENT BALLOON ANGIOPLASTY OF THE STUDY LESION. THE PHYSICIAN INDICATED THAT THE OCCLUSION/RESTENOSIS WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PRE-EXISTING PERIPHERAL VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THE EVENT.
(B)(6), OCCLUSION/RESTENOSIS REQUIRING INTERVENTION - POSSIBLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED VIA ULTRASOUND WITH AN OCCLUSION/RESTENOSIS OF THE LEFT DISTAL SFA OCCURRING WITHIN THE STUDY LESION. CLINICAL SIGNS AND SYMPTOMS INCLUDED NEW ONSET CLAUDICATION AND NUMBNESS. PRE-INTERVENTION MEASUREMENTS REVEALED THE RIGHT AND LEFT ABIS WERE 0.94 AND 0.54, RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND FOUR, RESPECTIVELY. ON (B)(6) 2016, THE PATIENT UNDERWENT BALLOON ANGIOPLASTY OF THE STUDY LESION. THE PHYSICIAN INDICATED THAT THE OCCLUSION/RESTENOSIS WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PRE-EXISTING PERIPHERAL VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THE EVENT.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE ADDITIONAL UPDATES RECEIVED IN RELATION TO THE REVIEW OF IMAGES RECEIVED FOR THIS EVENT. THIS ADDITIONAL UPDATE CHANGED THE FAILURE MODE OF THIS EVENT FROM RESTENOSIS TO THROMBOSIS. THE INVESTIGATION HAS BEEN UPDATED TO REFLECT THIS CHANGE. INITIAL EVENT DESCRIPTION SUBMITTED AS FOLLOWS: (B)(6), OCCLUSION REQUIRING INTERVENTION - POSSIBLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED VIA ULTRASOUND WITH AN OCCLUSION/RESTENOSIS OF THE LEFT DISTAL SFA OCCURRING WITHIN THE STUDY LESION. CLINICAL SIGNS AND SYMPTOMS INCLUDED NEW ONSET CLAUDICATION AND NUMBNESS. PRE-INTERVENTION MEASUREMENTS REVEALED THE RIGHT AND LEFT ABIS WERE 0.94 AND 0.54, RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND FOUR, RESPECTIVELY. ON (B)(6) 2016, THE PATIENT UNDERWENT BALLOON ANGIOPLASTY OF THE STUDY LESION. THE PHYSICIAN INDICATED THAT THE OCCLUSION WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PRE-EXISTING PERIPHERAL VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63318 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |