PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2021-01460
- Event Type
- Malfunction
- Date Received
- November 12, 2021
- Date of Event
- October 28, 2021
- Report Date
- January 19, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00763000284619
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT ANALYSIS: DOCUMENT USED: N/A AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THREE PIPELINE FLEX EMBOLIZATION DEVICES AND THREE PHENOM-27 CATHETERS WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN A RESEALABLE PLASTIC BAG. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: (PLI-20/PLI-40) THE PIPELINE FLEX WAS RETURNED STUCK WITHIN THE PHENOM-27 CATHETER HUB. THE PIPELINE FLEX WAS FOUND TO BE EXTENDING ~48.9CM FROM HUB. NO BENDS OR KINKS WERE FOUND WITH THE PIPELINE FLEX PUSHWIRE. AN ATTEMPT WAS MADE TO REMOVE THE PIPELINE FLEX FROM THE CATHETER; HOWEVER, DUE TO THE RESISTANCE THE PIPELINE WAS UNABLE TO BE REMOVED. ONCE THE CATHETER WAS DISSECTED (CUT) AT DISTAL TIP THE PIPELINE WAS THEN ABLE TO BE REMOVED. THE HYPOTUBE AND PTFE WERE FOUND TO BE INTACT. THE PROXIMAL BUMPER, PAD, AND PAD RESTRAINT WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND TO BE INTACT. THE TIP COIL WAS FOUND TO BE INTACT. DUE TO THE CONDITION IN WHICH THE BRAID WAS RETURNED, THE PROXIMAL AND DISTAL BRAID ENDS WERE UNABLE TO BE DETERMINED. BRAID END 1 WAS FOUND TO BE COLLAPSED AND FRAYED. BRAID END 2 WAS FOUND TO BE OPENED AND FRAYED. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): N/A CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL¿ WAS UNABLE TO BE CONFIRMED AS EACH DISTAL BRAID END OF THE PIPELINE FLEX BRAID WERE FOUND TO BE FULLY OPEN. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿RESISTANCE/STUCK DURING DELIVERY¿ WAS CONFIRMED AS THE PIPELINE FLEX DEVICES RETURNED STUCK WITHIN THE PHENOM CATHETERS USED DURING THE EVENT. 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. IN ADDITION, RESISTANCE CAN OCCUR DUE TO PATIENT VESSEL TORTUOSITY, FAILURE TO MAINTAIN A CONTINUOUS FLUSH, OR PIPELINE IS PULLED BACK/TORQUED DURING DELIVERY. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY AND A CONTINUOUS FLUSH WAS MAINTAINED. THEREFORE, THE CAUSE COULD NOT BE DETERMINED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE¿ WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR ¿CATHETER RESISTANCE¿ ARE CONTINUOUS FLUSH RATE TOO LOW, CATHETER OR DELIVERY SYSTEM DAMAGE OR INSUFFICIENT DELIVERY SYSTEM HYDRATION. IT IS POSSIBLE THE DAMAGE (KINKED/ACCORDIONED) FOUND WITH THE CATHETER BODY'S CONTR IBUTED TO THE RESISTANCE. 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.
SEE MANUFACTURER REPORT # 2029214-2021-01459 FOR ANOTHER PIPELINE INVOLVED IN THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED REPORTED ALL 3 CATHETERS WERE ACCORDIONING. AS MENTIONED BEFORE ALL 3 CATHETERS WERE FROM SAME LOT.
MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINES FAILED TO OPEN DISTALLY AND THERE WAS RESISTANCE IN THE PROXIMAL PART OF THREE PHENOM 27 MICROCATHETERS. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE RIGHT ICA. THE MAX DIAMETER WAS 8MM, AND THE NECK DIAMETER WAS 7MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.7MM DISTAL AND 4.7MM PROXIMAL. THE ACCESS VESSEL WAS THE RIGHT ICA, WHICH WAS 5MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 114. IT WAS REPORTED THAT THE FIRST PIPELINE WAS ADVANCED INTO THE MIDDLE CEREBRAL ARTERY. THE DISTAL OPENED AND THE DOCTOR PULLED IT BACK TO ITS DISTAL LANDING ZONE. THE MOST DISTAL PART OPENED WELL, BUT 2-3MM PROXIMAL TO THE DISTAL END THE DEVICE APPEARED CONSTRAINED. THE MAJORITY OF THE DEVICE WAS DEPLOYED AND ALL THE MIDSECTION COMPLETELY OPENED WITH THAT SMALL CONSTRAINED AREA UNCHANGED. THE DEVICE WAS RECAPTURED. IT WAS NOTICED THAT THE PRESSURE TO RESHEATH WAS DAMAGING TO THE PHENOM 27 CATHETER, AND IT WAS ACCORDIONING AT ITS PROXIMAL SECTION. BOTH THE PHENOM 27 AND PIPELINE WERE REMOVED FROM THE BODY AND REPLACED. THE EXACT SAME PROBLEM OCCURRED WITH THE CONSTRAINED DISTAL SECTION OF THE PIPELINE. THE PHENOM 27 AND PIPELINE WERE REPLACED AGAIN. THEY DECIDED TO TRY TO OPEN THE DEVICE IN THE DISTAL ICA, BUT THE SAME ISSUE OCCURRED. IT WAS OBSERVED THAT ALL THE PHENOM 27 CATHETERS WERE ALL FROM THE SAME LOT, SO IT WAS SUGGESTED TO USE A NEW CATHETER FROM TRUNK STOCK AS IT WAS THE ONLY THING EACH DEVICE HAD IN COMMON. THE IMPLANTED PIPELINE HAD SIGNIFICANTLY LESS FRICTION WHEN BEING ADVANCED THROUGH THE TRUNK STOCK PHENOM. THE FOURTH PIPELINE WAS ABLE TO BE DELIVERED AND DEPLOYED WITH EXPECTED RESULTS. IT WAS POSSIBLE THAT THE DEVICES WERE BEING DAMAGED IN THE CATHETER. THE PIPELINES HAD NOT BEEN POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN THEY FAILED TO OPEN. THE PIPELINES HAD BEEN RESHEATHED 2 OR LESS TIMES. NO ADDITIONAL STEPS OR DEVICES WERE USED TO OPEN THE DEVICES. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED A GOOD OUTCOME WITH THE FINAL DEVICE. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A NEURON MAX 088, NAVIEN 058 CATHETER, AND SYNCHRO SOFT GUIDEWIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1700564 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-475-16 | B260031 | 00763000284619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female |