PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2021-00719
- Event Type
- Malfunction
- Date Received
- June 11, 2021
- Date of Event
- June 9, 2021
- Report Date
- October 1, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- PMA / PMN Number
- P100018.S026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
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.
G4: 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.
PRODUCT ANALYSIS: AS FOUND CONDITION: THE PIPELINE FLEX W/ SHIELD DEVICE AND PHENOM-27 MICRO CATHETER WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN TWO SEALED BIOHAZARD POUCHES; AND WITHIN AN OPENED PIPELINE FLEX W/ SHIELD INNER POUCH. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO FLASH OR VOIDS MOLDED WERE FOUND WITHIN THE PHENOM-27 CATHETER HUB. THE PUSHER WAS FOUND EXTENDING OUT THE HUB ~46.0CM. NO DAMAGES OR ANOMALIES WERE FOUND WITH THE CATHETER HUB. THE PHENOM-27 CATHETER BODY WAS FOUND ACCORDIONED BETWEEN ~25.0CM AND ~29.0CM FROM THE PROXIMAL END. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE DISTAL TIP AND MARKER BAND. THE PIPELINE FLEX W/ SHIELD TIP COIL WAS FOUND EXTENDING OUT OF THE CATHETER DISTAL TIP. THE PIPELINE FLEX W/ SHIELD DEVICE COULD NOT BE ADVANCED OUT OR RETRACTED BACK WITHIN THE CATHETER AS IT WAS FOUND TO BE STUCK. THE CATHETER WAS CUT TO REMOVE THE DEVICE. NO DAMAGES WERE FOUND WITH THE PIPELINE FLEX W/ SHIELD PROXIMAL PUSHER. THE HYPOTUBE WAS FOUND INTACT AND UNSTRETCHED WITH THE PTFE SHRINK TUBING INTACT. THE DISTAL DELIVERY WIRE WAS FOUND SEPARATED FROM THE HYPOTUBE PROXIMAL TO THE WIRE WELD. THE RESHEATHING P AD, PROXIMAL BUMPER AND RESHEATHING MARKER WERE FOUND STILL ON THE DISTAL WIRE AND FOUND UNDAMAGED. THE PTFE DPS SLEEVES WAS FOUND UNDAMAGED. NO DAMAGES OR STRETCHING WAS OBSERVED WITH THE TIP COIL. ONCE RETRACTED OUT OF THE CATHETER, BOTH ENDS WERE FOUND FULLY OPENED, FRAYED, AND DAMAGED. TESTING/ANALYSIS: THE SEPARATED DISTAL WIRE WAS SENT OUT FOR EDS ANALYSIS. CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL (FLEX)¿ COULD NOT BE CONFIRMED. POSSIBLE CAUSES ARE DAMAGED CATHETER, DAMAGE TO PUSHWIRE, FRAYED ENDS ON BRAID, PATIENT VESSEL TORTUOSITY, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, OR USER PULLS BACK ON/TORQUES WIRE WHILE ADVANCING PED IN MICRO CATHETER. CUSTOMER REPORTED DEVICES WERE PREPARED PER IFU, STENT WAS LESS THAN 50% DEPLOYED, DEVICE NOT POSITIONED IN A VESSEL BEND, PIPELINE WAS RESHEATHED MORE THAN TWO TIMES, NO FRICTION/DIFFICULTY WERE OBSERVED. FROM THE DAMAGES SEEN ON THE BRAID (DAMAGED); DISTAL WIRE (SEPARATION), CATHETER (ACCORDION); IT APPEARS THERE WAS HIGH FORCE USED. IT IS POSSIBLE THESE DAMAGES OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE/RETRIEVE THE PIPELINE FLEX W/ SHIELD THROUGH THE PHENOM-27 CATHETER AGAINST RESISTANCE. POSSIBLE CONTRIBUTORS TOWARDS THE FAILURE ARE PATIENT VESSEL TORTUOSITY, OR LACK OF CONTINUOUS FLUSH. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE REPORTED ISSUES. THE DISTAL WIRE OF THE PIPELINE FLEX W/ SHIELD DELIVERY SYSTEM WAS POSSIBLY DETACHED DUE TO THE SOLDER TENSILE FAILURE WHEN ATTEMPTING TO RETRACT THE PIPELINE FLEX W/ SHIELD AGAINST RESISTANCE. A REVIEW OF THE MANUFACTURING PROCESS (MP1664, MP1647, MP1720, <(><<)>(><(>&<)><(> <<)>)> VS2022) DID NOT UNCOVER ANY DEFICIENCIES WITH REGARDS TO THE SOLDERING PROCESS. PROPER SOLDERING TECHNIQUE AND SURFACE PREPARATION (TINNING) WERE WELL DEFINED AND DOCUMENTED APPROPRIATELY IN THE ASSOCIATED MANUFACTURING PROCEDURES. IN ADDITION, THE ELEMENTAL ANALYSIS CONDUCTED THROUGH SCANNING ELECTRON MICROGRAPHIC (SEM) / ENERGY DISPERSIVE SPECTROSCOPY (EDS) SHOWED PRESENCE OF SOLDERING MATERIAL (TIN); THEREBY INDICATING THAT THE SOLDERING WAS CONDUCTED. THE PROOF LOAD OF 2.5N PERFORMED ON 100% OF THE DEVICES (SECTION STARTING WITH HYPOTUBE SOLDER TO DISTAL PAD SOLDER JOINT). THERE WAS NO NON-CONFORMANCE TO SPECIFICATION THAT LED TO THE DETACHMENT ISSUES. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING ISSUE. 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 THERE WAS NO DAMAGE TO THE PIPELINE STENT OR PUSHWIRE OBSERVED, AND THERE WAS NO FRICTION OR OTHER DIFFICULTY EXPERIENCED DURING DELIVERY OF THE DEVICE.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD THAT FAILED TO OPEN AT THE DISTAL END. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM. THE PIPELINE DEVICE AND ALL ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE DID NOT OPEN AT THE DISTAL END. THE STENT WAS LESS THAN 50% DEPLOYED WHEN IT FAILED TO OPEN. IT WAS NOT POSITIONED IN A VESSEL BEND. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO OTHER STEPS OR DEVICES WERE TRIED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THERE WAS NO HARM OR INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 878172 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-450-25 | B039992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |