PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2022-00165
- Event Type
- Malfunction
- Date Received
- February 6, 2022
- Date of Event
- June 1, 2019
- Report Date
- March 14, 2022
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- OUT
- PMA / PMN Number
- P100018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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.
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.
D. ATASOY, N. KANDASAMY, J. HART, J. LYNCH, S.-H. YANG, D. WALSH, C. TOLIAS, AND T.C. BOOTH; NEURORADIOL; 2019; 40:2094¿2101; OUTCOME STUDY OF THE PIPELINE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY IN UNRUPTURED ANEURYSMS (PEDSU); OUTCOME STUDY OF THE PIPELINE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY IN UNRUPTURED ANEURYSMS (PEDSU) MEDTRONIC RECEIVED INFORMATION VIA LITERATURE ARTICLE OF PATIENT'S THAT HAD COMPLICATIONS WITH PIPELINE 3 VANTAGE WITH SHIELD DEICES THAT INCLUDE RESISTANCE IN MARKSMAN CATHETER THROMBOSIS, HEMORRHAGE, BLURRY VISION, PAPILLEDEMA, PULSATILE TINNITUS, STROKE, FISTULA, AND STENT NOT COVERING NECK AT 5 MONTH FOLLOW UP. FORTY-FOUR ATTEMPTED PIPELINE SHIELD PROCEDURES WERE PERFORMED FOR 41 PATIENTS WITH 44 TARGET ANEURYSMS (TOTAL OF 52 ANEURYSMS TREATED). A TOTAL OF 88.5% OF DEVICES WERE INSERTED IN THE ANTERIOR CIRCULATION, AND 11.5%, IN THE POSTERIOR CIRCULATION; 49/52 (94.2%) ANEURYSMS WERE SACCULAR; AND 1/52 (1.9%) WAS FUSIFORM. ONE (1.9%) ANEURYSM WAS AN IATROGENIC PSEUDOANEURYSM, AND 1 (1.9%) WAS A DISSECTING ANEURYSM. SEVENTY-ONE PERCENT (35/49) OF THE SACCULAR ANEURYSMS WERE WIDE-NECK (NECK, .4 MM), 34.6% (18/52) WERE LARGE ($10 MM), AND 3.8% (2/52) WERE GIANT (> OR =25 MM). THE MEAN ANEURYSM SAC MAXIMAL DIAMETER WAS 9.0 MM, AND THE MEAN NECK WIDTH WAS 5.0 MM. THERE WERE 41 PATIENTS BETWEEN MARCH 2016 AND JANUARY 2018 WHOM WE INTENDED TO TREAT WITH THE PIPELINE SHIELD DEVICE. THE MEAN AGE WAS 56 YEARS (RANGE, 17¿82 YEARS), AND 68.3% (28/41) OF PATIENTS WERE WOMEN. PATIENTS STARTED DUAL-ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL) 7 DAYS BEFORE THEIR PROCEDURE AND CONTINUED CLOPIDOGREL ONCE DAILY FOR 6¿9MONTHS AND CONTINUED ASPIRIN FOR LIFE. ALL PROCEDURES WERE PERFORMED WITH A FEMORAL ARTERIAL APPROACH WITH 6F OR 8F GUIDING-CATHETER SYSTEMS. INCORPORATING A 0.058- OR 0.072-INCH INTRACRANIAL SUPPORT CATHETER WAS USED IN BOTH THE ANTERIOR AND POSTERIOR CIRCULATIONS. THE PIPELINE SHIELD DEVICE WAS DEPLOYED USING A 0.027-INCH MICROCATHETER (PHENOM 27 OR MARKSMAN). NO THROMBOEMBOLIC OR HEMORRHAGIC EVENTS OCCURRED DURING THE PROCEDURES. DEVICE-DEPLOYMENT SUCCESS (RELEASE OF THE PIPELINE SHIELD AT THE TARGET SITE) WAS ACHIEVED IN 45 OF 46 (97%) OF THE ATTEMPTED PIPELINE SHIELD DEPLOYMENTS. DEPLOYMENT WAS UNSUCCESSFUL BECAUSE THE PIPELINE SHIELD WOULD NOT TRAVEL THROUGH THE MARKSMAN CATHETER. ANOTHER PATIENT HAD AN ACUTE SUBDURAL HEMATOMA 15 DAYS AFTER THE SUCCESSFUL PIPELINE SHIELD DEPLOYMENT WITH ADJUNCTIVE COILING AND DIED 16 DAYS AFTER THE PROCEDURE. THE SECOND MAJOR EVENT WAS THE PATIENT WAS TREATED WITH 2 PIPELINE SHIELD DEVICES FOR A GIANT (28MM) RIGHT CAVERNOUS SEGMENT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. ON DAY 7 POSTPROCEDURE, THE PATIENT WAS RE-ADMITTED WITH AN IPSILATERAL THIRD NERVE PALSY. A HEAD CT REVEALED THE EXPECTED APPEARANCES OF A THROMBOSED ANEURYSM. THE THIRD CRANIAL NERVE PALSY WAS ATTRIBUTED TO THE THROMBOSED ANEURYSM. AT THE TIME OF PRESENTATION, THE PATIENT ALSO EXPERIENCED A HEADACHE. THERE WERE 2 PERIPROCEDURAL MINOR EVENTS, INCLUDING THE HEADACHE. THE SECOND MINOR EVENT YIELDED A 2.3% (1/44) STROKE/TIA RATE. THIS PATIENT HAD A TIA WITH A TEMPORARY LEFT-SIDED FACIAL DROOP AND SLURRED SPEECH 6 DAYS AFTER RIGHT ICA PED DEPLOYMENT. ONE PATIENT DIED 16 DAYS POSTPROCEDURE. WITHIN 6 MONTHS OF PROCEDURE 36/52 HAD COMPLETE OCCLUSION (RAYMOND SCALE 1), 41/52 HAD ADEQUATE OCCLUSION (RAYMOND SCALE 1 OR 2), 3 ANEURYSMS WERE NONOCCLUDED. BETWEEN 6 AND 18 MONTHS SIX ADDITIONAL ANEURYSMS WERE COMPLETELY OCCLUDED. MRA AT 5 MONTHS SHOWED THE STENT WAS NO LONGER COVERING THE ENTIRE ANEURYSM NECK. THE ANEURYSM WAS RE-TREATED WITH A LARGER DIAMETER FLOW-DIVERTER DEVICE. THERE WAS 1 FURTHER MAJOR ADVERSE EVENT. THIS PATIENT HAD A RECURRENT LEFT CAVERNOUS SEGMENT ICA 9.5-MM WIDE-NECK ANEURYSM AFTER COILING. DURING THE PROCEDURE, THERE WAS A TRANSIENT IATROGENIC CAROTID CAVERNOUS FISTULA, WHICH HAD RESOLVED BY THE END OF THE PROCEDURE WHEN THE PIPELINE SHIELD WAS SATISFACTORILY DEPLOYED ACROSS THE NECK OF THE ANEURYSM. HOWEVER, THE PATIENT PRESENTED WITH SUDDEN-ONSET PULSATILE TINNITUS 1MONTH LATER, AND DSA SHOWED THAT THERE WAS RECURRENT CAROTID CAVERNOUS FISTULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595191 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MEDTRONIC EUROPE SARL | UNK-NV-PED2 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention |