PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2020-00784
- Event Type
- Malfunction
- Date Received
- August 11, 2020
- Date of Event
- August 7, 2020
- Report Date
- November 13, 2020
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ANALYSIS: EQUIPMENT USED: VIS (M-78210), 203CM RULER (M-83361) THE PIPELINE FLEX EMBOLIZATION DEVICE AND MARKSMAN MICROCATHETER WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN AN OPENED PIPELINE FLEX OUTER CARTON (A983470). AN OPENED MARKSMAN CATHETER OUTER CARTON WAS ALSO RETURNED; HOWEVER, WAS FOUND EMPTY. THE PIPELINE FLEX EMBOLIZATION DEVICE WAS RETURNED WITHIN THE CATHETER HUB; HOWEVER, DURING HANDLING THE PIPELINE FLEX INTRODUCER SHEATH DISENGAGED FROM WITHIN THE HUB. NO BENDS OR KINKS WERE FOUND WITH THE PIPELINE FLEX PUSHER. THE INTRODUCER SHEATH WAS FOUND INVERTED ON THE PUSHER. THE PIPELINE FLEX PUSHER APPEARED TO BE SEPARATED (DETACHED) WHEN EXAMINED WITHIN THE INTRODUCER SHEATH. THE PUSHER WAS REMOVED FROM WITHIN THE INTRODUCER SHEATH FOR FURTHER EXAMINATION. THE PIPELINE FLEX DISTAL HYPOTUBE WAS FOUND STRETCHED WITH THE PTFE SHRINK TUBING INTACT. THE PIPELINE FLEX PUSHER WAS FOUND DETACHED AT THE DISTAL HYPOTUBE WELD (SOLDER JOINT). THE PIPELINE FLEX DETACHED DISTAL SEGMENT WAS FOUND PROTRUDING FROM WITHIN THE CATHETER HUB. IN ADDITION, THE PIPELINE FLEX BRAID WAS FOUND DEPLOYED WITHIN THE CATHETER HUB. THE PIPELINE FLEX BRAD AND DETACHED DISTAL SEGMENT WERE REMOVED FROM WITHIN THE CATHETER HUB WITH RESISTANCE. THE PIPELINE FLEX BRAID WAS FOUND IN GOOD CONDITION WITH THE ENDS FULLY OPEN. THE PROXIMAL BUMPER, RESHEATHING PAD/MARKER, PTFE SLEEVES, DISTAL MARKER, AND TIP COIL WERE FOUND DETACHED FROM DISTAL CORE WIRE. THE DETACHED PUSHWIRE WAS SENT OUT FOR SEM (SCANNING ELECTRON MICROGRAPHIC) / EDS (ENERGY DISPERSIVE SPECTROSCOPY) ELEMENTAL ANALYSIS. THE ELEMENTAL ANALYSIS OF THE DETACHED PUSHWIRE END SHOWS THE PRESENCE OF TIN (SN). THE CATHETER WAS EXAMINED. NO BENDS OR KINKS WERE FOUND WITH THE CATHETER BODY. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE CATHETER DISTAL MARKER/TIP. THE CATHETER TOTAL LENGTH WAS MEASURED TO BE ~145.0CM AND THE USEABLE LENGTH WAS MEASURED TO BE ~137.5CM. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN¿ COULD NOT BE CONFIRMED, AS THE DEVICE HAS BEEN FULLY DEPLOYED AND RE-SHEATHED. POSSIBLE CAUSES FOR FAILURE TO OPEN ARE PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO ANATOMY, BRAID WAS OVERSTRETCHED DURING DELIVERY, USER DEPLOYS BRAID IN VESSEL BEND, PRESENCE OF OTHER INDWELLING ENDOVASCULAR STENTS, OR INAPPROPRIATE ANATOMY. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. REGARDING THE CUSTOMER¿S REPORT OF ¿LOCKUP/RESISTANCE AT DISTAL SEGMENT OF CATHETER¿ THE ISSUE COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITHIN THE PROXIMAL SEGMENT OF THE MARKSMAN CATHETER (HUB). NO DEFECT WAS FOUND WITH THE RETURNED MARKSMAN CATHETER THAT WOULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE. THE INVESTIGATION DETERMINED THAT THIS EVENT WAS SIMILAR TO AN EVENT THAT HAD ALREADY BEEN INVESTIGATED, AND ANOTHER INVESTIGATION IS NOT NECESSARY. BASED ON THE INVESTIGATION CONDUCTED RESISTANCE CAN OCCUR DURING TRACKING, DEPLOYMENT AND RE-SHEATHING OF THE DEVICE IN DISTAL AND TORTUOUS ANATOMIES. IT IS LIKELY THE PUSHER BECAME STRETCHED SUBSEQUENTLY DETACHING DUE TO THE REPORTED RESISTANCE. HOWEVER, THE CAUSE FOR THE RESISTANCE COULD NOT BE DETERMINED. REGARDING THE SOLDER JOINT SEPARATION ISSUE, SEPARATION CAN OCCUR DUE TO EXCESSIVE FORCE OR INADEQUATE SOLDER/TINNING. AS THE ANALYSIS SHOWED PRESENCE OF SOLDERING MATERIAL (TIN); THEREBY INDICATING THAT THE SOLDERING WAS CONDUCTED. A REVIEW OF THE MANUFACTURING PROCESS DID NOT UNCOVER ANY DEFICIENCIES WITH REGARD TO THE SOLDERING PROCESS. PROPER SOLDERING TECHNIQUE AND SURFACE PREPARATION (TINNING) WERE WELL DEFINED AND DOCUMENTED APPROPRIATELY IN THE ASSOCIATED MANUFACTURING PROCEDURES. 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 N ON-CONFORMANCE TO SPECIFICATION THAT LEAD TO THE RESISTANCE AND DETACHMENT ISSUES. FURTHERMORE, THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY IN SPECTION. THE INVESTIGATION DETERMINED THAT THIS EVENT IS SIMILAR TO EVENTS THAT HAD ALREADY BEEN INVESTIGATED, AND ANOTHER INVESTIGATION IS NOT NECESSARY. 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.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE PHYSICIAN TRIED TO RESHEATH THE PIPELINE, BUT IT STUCK IN THE MARKSMAN AND COULD NOT BE RESHEATHED OR ADVANCED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO EXPAND AND THEN BECAME STUCK IN THE MARKSMAN MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.1MM AND A 2.7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE PIPELINE WAS DEPLOYED APPROXIMATELY 1MM, WAS NOT EXPANDED. THEN THE PIPELINE WAS STUCK, AND IT COULD NOT BE ADVANCED OR RESHEATHED. SINCE THE PIPELINE WAS NOT EXPANDED, THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM OUT OF THE BODY INCLUDING THE MARKSMAN MICROCATHETER. AFTERWARD, A NEW MARKSMAN AND PIPELINE WERE USED, AND THE PROCEDURE WAS COMPLETED WITH NO ISSUE. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED GOOD RESULTS. 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. ANCILLARY DEVICES INCLUDE AN AVIGO GUIDEWIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 855376 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-425-18 | A983470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |