TELESCOPE GUIDE EXTENSION CATHETER
Report
- Report Number
- 9612164-2021-04346
- Event Type
- Injury
- Date Received
- November 11, 2021
- Date of Event
- November 6, 2021
- Report Date
- November 8, 2022
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- DQY
- PMA / PMN Number
- K183353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: THE PATIENT REPORTED EXERTIONAL ANGINA DURING EVALUATION FOR LOWER EXTREMITY REVASCULARIZATION. THE PATIENT WAS TURNED DOWN FOR CORONARY ARTERY BYPASS SURGERY DUE TO FRAILTY AND PERIPHERAL ARTERIAL DISEASE, AND WAS REFERRED FOR LAD AND RCA PERCUTANEOUS CORONARY INTERVENTIONS (PCI). ARTERIAL ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND THE RIGHT RADIAL ARTERY WITH 8-FRENCH AND 7 FRENCH SHEATHS, RESPECTIVELY. DUE TO SIGNIFICANT DIFFICULTY ENGAGING THE CORONARY ARTERIES VIA RADIAL ACCESS, LEFT FEMORAL ACCESS WAS SUCCESSFULLY OBTAINED DESPITE A KNOWN SEVERE LEFT ILIAC STENOSIS. THE PROCEDURAL PLAN WAS TO TREAT THE RCA LESION, FOLLOWED BY RETROGRADE CROSSING OF THE LAD CTO VIA SEPTAL COLLATERALS, AS LONG AS TREATMENT OF THE RCA WAS SUCCESSFUL. THE RCA LESION WAS BALLOON UN-CROSSABLE, REQUIRING MULTIPLE ROUNDS OF ORBITAL ATHERECTOMY. THE LESION WAS STENTED WITH A 3.0 X 38MM AND 3.0 X 26MM DRUG-ELUTING STENTS USING A 6FR MEDTRONIC TELESCOPE GEC. THE PROCEDURE THEN PROCEEDED WITH PCI OF THE LAD CTO. THE TELESCOPE FRAGMENT BECAME DISLODGED AT THE LEFT COMMON FEMORAL SHEATH AND EMBOLIZED IN A BRANCH OF THE LEFT EXTERNAL ILIAC ARTERY. A NON-MDT GEC WAS ADVANCED INTO THE PROXIMAL LAD, FOLLOWED BY SUCCESSFUL REVERSE CONTROLLED ANTEGRADE AND RETROGRADE TRACKING (CART) AND EXTERNALIZATION OF A NON-MDT GUIDEWIRE. THE PATIENT DEVELOPED ST SEGMENT ELEVATION. INJECTION OF THE RCA SHOWED A DISTAL EDGE DISSECTION. EQUIPMENT DELIVERY TO THE DISTAL RCA WAS VERY CHALLENGING DUE TO CALCIFICATION AND TORTUOSITY. TWO 3.0 X 18MM NON-MDT DRUG ELUTING STENT (DES) WERE ALSO IN USE. THE NON-MEDTRONIC STENTS FAILED TO DELIVER, AND DURING ATTEMPTED RETRIEVAL OF ONE OF THE STENT INTO THE GEC THE STENT DISLODGED AND CAME OFF THE BALLOON. SEVERAL BALLOONS WERE INFLATED AND THE STENT WAS EXPANDED. ONE OF THE BALLOONS RUPTURED RESULTING IN SUBINTIMAL STAINING IN THE DISTAL RCA. A NEW NON-MDT GEC WAS INSERTED AND A 3.0 X 18MM STENT WAS SUCCESSFULLY DELIVERED IN THE DISTAL RCA, RE-ESTABLISHING TIMI 3 ANTEGRADE FLOW. DESPITE ADEQUATE RCA FLOW, ST ELEVATION PERSISTED. BALLOON DILATION WAS PERFORMED IN THE CIRCUMFLEX AND LAD. ONE OF THE BALLOONS USED FOR POST-DILATION OF THE MID LAD STENTS RUPTURED, CAUSING STAINING. STENTING OF THE LEFT MAIN BIFURCATION USING THE DOUBLE KISSING (DK) CRUSH TECHNIQUE WAS PERFORMED, AS THE DISSECTION EXTENDED MORE PROXIMALLY. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO OPTIMIZE STENT IMPLANTATION. BECAUSE OF PERSISTENT STAINING IN THE LAD A 3.0 X 20MM NON-MDT COVERED STENT WAS DEPLOYED. AT THE CONCLUSION OF THE PROCEDURE THE RIGHT UPPER EXTREMITY WAS SWOLLEN AROUND THE ELBOW BUT WITH NO NEUROVASCULAR COMPROMISE. AN ALL-COTTON ELASTIC WRAP WAS APPLIED. THE LOWER EXTREMITIES WERE PALE AND PULSELESS. PERIPHERAL ANGIOGRAPHY DEMONSTRATED SEVERE DISEASE OF BOTH LOWER EXTREMITIES WITH OCCLUDED BILATERAL SUPERFICIAL FEMORAL ARTERIES BUT PATENT PROFUNDA FEMORAL ARTERIES. THE SHEATHS WERE REMOVED AND MANUAL PRESSURE WAS HELD, BUT A RIGHT GROIN HEMATOMA FORMED FOLLOWED BY VENTRICULAR TACHYCARDIA AND CARDIAC ARREST. THE PATIENT WAS CANNULATED AND PLACED ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANOUS OXYGENATION (VA-ECMO). REPEAT CORONARY ANGIOGRAM SHOWED PATENT STENTS. DUE TO PERSISTENT LOW FLOWS ON VA-ECMO DESPITE AGGRESSIVE RESUSCITATION WITH MASSIVE BLOOD TRANSFUSION, BILATERAL ILIAC ARTERY STENTING AND FEMORAL DACRON TUBE GRAFT PLACEMENT WAS REQUIRED. THE PATIENT WAS DISCHARGED 19 DAYS LATER, AND AT TWO MONTH FOLLOW-UP THE PATIENT HAD NO ANGINA AND WAS PROGRESSING WITH CARDIAC REHABILITATION. THE DISTAL RCA DISSECTION MAY HAVE BEEN CAUSED BY THE INITIALLY PLACED NON-MEDTRONIC RCA STENTS. THE LAD PERFORATION WAS CAUSED BY NON-MDT BALLOON RUPTURE AFTER STENTING. AS PER THE PHYSICIAN, THERE WAS NO CASUAL RELATIONSHIP BETWEEN THE TELESCOPE DEVICES AND EITHER THE RCA DISSECTION OR THE LAD PERFORATION. THE CAUSE OF CARDIAC ARREST IS UNCLEAR BUT MAY HAVE BEEN PRECIPITATED BY BLEEDING AT THE ACCESS SITE. THE CAUSE OF THE PERSISTENT ST ELEVATION WAS ALSO UNCLEAR. PATIENT GENDER, AGE AND PAST MEDICAL HISTORY PROVIDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: AN ATTEMPT WAS MADE TO USE TWO TELESCOPE GUIDE EXTENSION CATHETERS. THE FIRST DEVICE WAS ATTEMPTED TO BE USED TO TREAT A HEAVILY CALCIFIED LESION WITH TOTAL CHRONIC OCCLUSION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE SECOND DEVICE WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY CALCIFIED AND TORTUOUS STENTED DISTAL RIGHT CORONARY ARTERY (RCA). THIS WAS A BACKUP CASE FOR TRANSCATHETER CARDIOVASCULAR THERAPEUTICS (TCT) AND WAS DEFERRED FROM LIVE TRANSMISSION DUE TO ITS COMPLEXITY. THE TELESCOPES WERE USED AFTER THE INABILITY TO ADVANCE BALLOONS ACROSS THE LESIONS. RESISTANCE OCCURRED AFTER INCH WORMING BOTH TELESCOPES AND EMBEDDING THE CATHETER INTO THE CALCIFIED LESIONS. FOR THE FIRST DEVICE, DURING LAD INTERVENTION. A NON-MDT MICROCATHETER AND NON-MDT 2.0X15 MM BALLOON WERE DELIVERED WITHIN AND DISTAL TO THE TELESCOPE TO INCHWORM THE CATHETER FORWARD INTO THE LESION. A RETROGRADE APPROACH WAS ALSO USED BUT THE LESION COULD NOT BE CROSSED. UPON REMOVAL OF THE TELESCOPE, THE TIP FRACTURED. IT WAS STATED THAT DURING THE ATTEMPTED RETRIEVAL WITH A BALLOON, THE TIP EMBOLIZED TO THE LEG INTO THE PERIPHERAL VASCULAR BED WHERE IT WAS LEFT WITHOUT SEQUELAE. THE TELESCOPE WAS ADVANCED DISTALLY BUT BECAME TRAPPED BETWEEN TWO STENTS AND FRAGMENTED. UPON REMOVAL OF THE TELESCOPE, THE TIP FRACTURED AND DURING ITS ATTEMPTED RETRIEVAL WITH A BALLOON, IT EMBOLIZED TO THE DISTAL POSTEROLATERAL SEGMENT ARTERY (PLSA) WHERE IT WAS LEFT WITHOUT SEQUELAE. DURING THE USE OF THE SECOND DEVICE IN THE RCA INTERVENTION, THE TELESCOPE WAS ADVANCED DISTALLY BUT BECAME TRAPPED BETWEEN TWO STENTS AND FRAGMENTED. UPON REMOVAL OF THE TELESCOPE, THE TIP FRACTURED AND DURING ITS ATTEMPTED RETRIEVAL WITH A BALLOON, IT EMBOLIZED TO THE DISTAL POSTEROLATERAL SEGMENT ARTERY (PLSA) WHERE IT WAS LEFT WITHOUT SEQUELAE. THIS WAS ULTRACOMPLEX LESIONS TO THE CALCIFIED DISTAL RCA AND PROXIMAL LAD AND WAS ULTIMATELY NOT SUCCESSFUL. THE PHYSICIAN FELT THAT THE EXCESS TORSION AND EMBEDDING THE TELESCOPES INTO THE CALCIFIED LESIONS ATTRIBUTED TO THE FRACTURES. IT WAS STATED THAT THE TIP DETACHMENTS WERE NOT RELATED TO ANY OTHER COMPLICATIONS OR OTHER DEVICES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: THE RCA WAS SEVERELY CALCIFIED. FOR THE FIRST DEVICE, DURING LAD INTERVENTION, A NON-MEDTRONIC (MDT) GUIDEWIRE AND A NON-MDT DUAL LUMEN CATHETER (DLC) WERE USED. A NON-MDT 2.0X15 MM BALLOON WAS DELIVERED WITHIN AND DISTAL TO THE TELESCOPE. WHEN ATTEMPTING TO CAPTURE THE TELESCOPE THE BALLOON WAS POSITIONED DISTALLY. THE BALLOON WAS INFLATED CLOSE TO NOMINAL PRESSURE. THE TIP OF THE TELESCOPE WAS NOT FULLY REMOVED FROM THE PATIENT. DURING THE USE OF THE SECOND DEVICE IN THE RCA INTERVENTION, A NON-MDT DRUG ELUTING STENT (DES), A NON-MEDTRONIC POBA AND A NON-MEDTRONIC BALLOON DILATION CATHETER WERE ALSO IN USE. THE NON-MEDTRONIC DES DISLODGED. THE PHYSICIAN SUGGESTED THAT THE DISLODGEMENT WAS CAUSED BY THE SEVERE LESION CALCIFICATION. THE PHYSICIAN ALSO SUGGESTED THAT THE TELESCOPE TIP WAS FRACTURED BY THE BALLOON INFLATION. IT WAS INDICATED THAT THE MARKERBAND OF THE TELESCOPE EMBOLISED. NO FURTHER PATIENT INJURY WAS REPORTED. CORRECTION: LOT NUMBER PROVIDED. IT WAS INDICATED THAT THE PROCEDURE WAS VERY CHALLENGING AND THE DEVICES WERE PUSHED AGAINST THE CALCIUM QUITE A BIT IN ORDER TO ADVANCE THE DEVICES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ANALYSIS//IMAGE REVIEW: THE FIRST DEVICE (PLI10) WAS ATTEMPTED TO BE USED TO TREAT A HEAVILY CALCIFIED LESION WITH TOTAL CHRONIC OCCLUSION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A REVIEW OF THE CINE IMAGES RECEIVED IN A POWERPOINT PRESENTATION REVEALED A CTO TO THE LAD WITH IDENTIFICATION OF A LM FILLING DEFECT. THE LAD CONNECTED WITH COLLATERALS FROM THE RCA VIA SEPTALS. THE PROXIMAL TO MID-RCA WAS TREATED FIRST. TREATMENT OF THE LAD WAS ATTEMPTED; A GW WAS ADVANCED THROUGH THE CTO OF THE LAD. THE COMPLEXITY OF THIS PROCEDURE WAS CONFIRMED BASED ON THE FAILED DELIVERY OF WIRES, REQUIRING RETROGRADE APPROACH THROUGH THE RCA SEPTALS TO BE USED. THE CARLINO TECHNIQUE USED TO INJECT CONTRAST THROUGH THE MICRO-CATHETER INTO LAD, FOLLOWED BY RETROGRADE DELIVERY OF FIELDER XT WIRE INTO PROXIMAL LAD TOWARDS THE LM AND CTO. CONTRAST INJECTION SHOWED LIMITED FLOW. ATTEMPTED DELIVERY OF A 6F TELESCOPE OVER THE DEFLATED BALLOON WAS IDENTIFIED, THE TIP OF THE TELESCOPE GEC COULD BE SEEN MIDWAY OVER BALLOON WORKING LENGTH. THE PHYSICIAN REPORTED THAT THE 6F TELESCOPE GEC WOULD NOT ADVANCE. TWO PROCEDURAL WIRES AND ONE BALLOON CATHETER DELIVERY SYSTEM COULD BE SEEN IN THE VASCULATURE IN ADDITION TO THE GC AND THE GEC. ON SLIDE 35 THE INTRODUCTION OF 6F TELESCOPE GEC INTO LAD WAS IDENTIFIED, NO IMAGES TO SHOW THAT ANY DEVICES WERE DELIVERED THROUGH THE GEC IN THE LAD WERE PROVIDED. MICRO-CATHETERS AND WIRES WERE USED PRIOR TO GEC INTRODUCTION. THE TIP FRACTURE WAS REPORTED ON SLIDE 36, HOWEVER NEITHER THE BALLOON NOR TELESCOPE GEC WERE NOT VISIBLE IN THE IMAGES. A BALLOON WAS DELIVERED TO THE PROXIMAL LAD, NO GEC WAS VISIBLE BUT POSSIBLE ARTEFACT OF THE GEC MARKERBAND WAS VISIBLE JUST DISTAL TO GC TIP PROXIMAL TO SMALL BALLOON THAT HAS NOT BEEN INFLATED. INFLATION OF THE SMALL BALLOON FAILED TO CATCH THE DETACHED PORTION OF THE 6F TELESCOPE GEC. ANTEGRADE WIRES WERE REMOVED FROM THE LAD. RETROGRADE WIRE REMAINED IN PLACE. THE GC, DETACHED TIP AND WIRES WERE REMOVED THROUGH THE DESCENDING AORTA. WHAT IS DESCRIBED AS THE EMBOLISED TIP WAS IDENTIFIED IN THE COMMON FEMORAL ARTERY. THE TIP APPEARED TO BE HORSE-SHOE SHAPED, SUGGESTING THAT THE DETACHED MARKERBAND WAS BROKEN/FRACTURED. PRODUCT ANALYSIS/IMAGE REVIEW: A REVIEW OF THE PROCEDURAL IMAGES SHOWED THE REPORTED DETACHED APPEARED TO BE HORSE-SHOE SHAPED, SUGGESTING THAT THE DETACHED MARKERBAND WAS BROKEN/FRACTURED. THE MECHANISM OF DETACHMENT WAS NOT CAPTURED IN THE RETURNED IMAGES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
AN ATTEMPT WAS MADE TO USE TWO TELESCOPE GUIDE EXTENSION CATHETERS. THE FIRST DEVICE WAS ATTEMPTED TO BE USED TO TREAT A HEAVILY CALCIFIED LESION WITH TOTAL CHRONIC OCCLUSION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE SECOND DEVICE WAS ATTEMPTED TO BE USED TO TREAT A CALCIFIED AND TORTUOUS STENTED RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU. IT WAS REPORTED THAT THE TIP OF BOTH DEVICES FRACTURED AND EMBOLIZED DURING THE PROCEDURE. IT WAS STATED THAT THIS IS A CRITICALLY ILL PATIENT. IT WAS ALSO STATED THAT THE PROCEDURE WAS 15 HOURS LONG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1696430 | TELESCOPE GUIDE EXTENSION CATHETER | CATHETER, PERCUTANEOUS | DQY | MEDTRONIC IRELAND | 0010733252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |