PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2021-00654
- Event Type
- Malfunction
- Date Received
- June 3, 2021
- Date of Event
- May 26, 2021
- Report Date
- May 17, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G3: PMA/510(K) CORRECTED. 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.
PMA# P100018.S026 WAS OMITTED FROM PREVIOUS REPORT IN ERROR. 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.
H3: THE PIPELINE FLEX SHIELD AND PHENOM 27 CATHETER WERE RETURNED INSIDE OF A BIOHAZARD BAG AND A SHIPPING BOX. ¿ VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE FOUND TO BE INTACT WITH NO SIGNS OF ELONGATION. THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX SHIELD BRAID WERE FULLY OPENED AND MODERATELY FRAYED. NO BEND FOUND ON THE PUSHER. NO DAMAGES WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER OR WITH THE PROXIMAL BUMPER. THE CATHETER TIP, MARKER AND BODY WERE EXAMINED; NO DAMAGES WERE FOUND. NO OTHER ANOMALIES WERE OBSERVED. ¿ TESTING/ANALYSIS: THE PIPELINE FLEX SHIELD WAS PUSHED OUT FROM THE CATHETER LUMEN WITH NO ISSUES. THE TOTAL AND USABLE LENGTHS OF THE PHENOM 27 CATHETER WERE FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND WATER EXITED OUT FROM THE DISTAL TIP. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.0265¿ MANDREL THROUGH CATHETER HUB. THE MANDREL SUCCESSFULLY PASSED THROUGH THE CATHETER HUB, LUMEN AND TIP WITH NO ISSUES. ¿ CONCLUSION: BASED ON THE RETURNED DEVICE, THE PIPELINE FLEX SHIELD WAS NOT CONFIRMED TO HAVE FAILURE TO OPEN AT THE DISTAL END AS THE DISTAL AND PROXIMAL ENDS OF PIPELINE FLEX SHIELD BRAID WERE FULLY OPENED AND MODERATELY FRAYED. THE DAMAGE TO THE BRAID ON THE ENDS OF THE PIPELINE FLEX SHIELD IS LIKELY THE RESULTS OF THE PHYSICIAN RE-SHEATHING THE DEVICE MORE THAN RECOMMENDED TWO TIMES. IT IS LIKELY THAT THE SEVERE VESSEL TORTUOSITY MAY HAVE CONTRIBUTED TO THE FAILURE TO OPEN ISSUE. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE FAILURE TO OPEN ISSUE. NO DAMAGES WAS FOUND WITH THE RETURNED CATHETER. PER OUR INSTRUCTIONS FOR USE (IFU): ¿BEGIN TO DELIVER THE DEVICE USING A COMBINATION OF UNSHEATHING THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE AND PUSHING DELIVERY WIRE SIMULTANEOUSLY. AFTER THE DISTAL END OF THE PIPELINE FLEX SHIELD SHIELD EMBOLIZATION DEVICE HAS SUCCESSFULLY EXPANDED, DEPLOY THE REMAINDER OF PIPELINE FLEX SHIELD EMBOLIZATION DEVICE BY PUSHING THE DELIVERY WIRE AND/OR UNSHEATHING THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE. RESHEATHING AND/OR MANIPULATION OF THE MICRO CATHETER, BY LOCKING DOWN THE DELIVERY WIRE AND MOVING BOTH AS A SYSTEM, MAY FACILITATE EXPANSION OF THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE. THE SYSTEM IS DESIGNED TO ALLOW FOR 2 FULL CYCLES OF RE-SHEATHING OF THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE. RE-SHEATHING THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE MORE THAN 2 FULL CYCLES MAY CAUSE DAMAGE TO THE DISTAL OR PROXIMAL ENDS OF THE BRAID. DO NOT USE IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES THE ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT, DUE TO CONDITIONS SUCH AS SEVERE INTRACRANIAL VESSEL TORTUOSITY OR STENOSIS.¿ 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.
H3. PRODUCT ANALYSIS: THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE FOUND TO BE INTACT WITH NO SIGNS OF ELONGATION. THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX SHIELD BRAID WERE FULLY OPENED AND MODERATELY FRAYED. NO BEND FOUND ON THE PUSHER. NO DAMAGES WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER OR WITH THE PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE RETURNED DEVICE, THE PIPELINE FLEX SHIELD WAS NOT CONFIRMED TO HAVE FAILURE TO OPEN AT THE DISTAL END AS THE DISTAL AND PROXIMAL ENDS OF PIPELINE FLEX SHIELD BRAID WERE FULLY OPENED AND MODERATELY FRAYED. THE DAMAGE TO THE BRAID ON THE ENDS OF THE PIPELINE FLEX SHIELD IS LIKELY THE RESULTS OF THE PHYSICIAN RE-SHEATHING THE DEVICE MORE THAN RECOMMENDED TWO TIMES. IT IS LIKELY THAT THE SEVERE VES SEL TORTUOSITY MAY HAVE CONTRIBUTED TO THE FAILURE TO OPEN ISSUE. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE FAILURE TO OPEN ISSUE. PER OUR INSTRUCTIONS FOR USE (IFU): ¿BEGIN TO DELIVER THE DEVICE USING A COMBINATION OF UNSHEATHING THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE AND PUSHING DELIVERY WIRE SIMULTANEOUSLY. AFTER THE DISTAL END OF THE PIPELINE FLEX SHIELD SHIELD EMBOLIZATION DEVICE HAS SUCCESSFULLY EXPANDED, DEPLOY THE REMAINDER OF PIPELINE FLEX SHIELD EMBOLIZATION DEVICE BY PUSHING THE DELIVERY WIRE AND/OR UNSHEATHING THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE. RESHEATHING AND/OR MANIPULATION OF THE MICRO CATHETER, BY LOCKING DOWN THE DELIVERY WIRE AND MOVING BOTH AS A SYSTEM, MAY FACILITATE EXPANSION OF THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE. THE SYSTEM IS DESIGNED TO ALLOW FOR 2 FULL CYCLES OF RE-SHEATHING OF THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE. RE-SHEATHING THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE MORE THAN 2 FULL CYCLES MAY CAUSE DAMAGE TO THE DISTAL OR PROXIMAL ENDS OF THE BRAID. DO NOT USE IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES THE ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT, DUE TO CONDITIONS SUCH AS SEVERE INTRACRANIAL VESSEL TORTUOSITY OR STENOSIS.¿ 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 RECEIVED INDICATED THE REPORT OF "PROCEDURE WAS ABORTED TO AVOID POSSIBLE ADVERSE EVENTS" WAS CLARIFIED TO MEAN THERE WAS CESSATION OF THE USE OF THE PIPELINE, BUT ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE TREATMENT.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED A REPORT THAT THE 4.75 MM DIAMETER DEVICE WAS USED, AND THE ANATOMY WAS UNFAVORABLE. THE FIRST DEVICE FAILED TO OPEN IN THE DISTAL SEGMENT. THE PHYSICIAN RE-SHEATHED ONCE TO ENCOURAGE OPENING, AND THE MIDDLE OF THE STENT OPENED, BUT THE DISTAL END STILL DID NOT. THE SAME STEPS WERE PERFORMED WITH A SECOND PIPELINE, AND EVENTUALLY, THE PHYSICIAN DID GET THE PIPELINE TO OPEN DISTALLY. HOWEVER, THE STENT POSITION WAS SUBOPTIMAL AT THAT TIME, AND SO THE PROCEDURE WAS ABORTED TO AVOID POSSIBLE ADVERSE EVENTS. A REPLACEMENT PRODUCT FROM ANOTHER MANUFACTURER WAS USED INSTEAD. IT WAS NOTED THE PIPELINES WERE NOT POSITIONED IN A BEND, AND RE-SHEATHING WAS DONE LESS THAN THREE TIMES. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING (PCOM) ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 828493 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-475-16 | A692848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female |