PULSERIDER Y 3MM, 8MM ARCH
Report
- Report Number
- 3008680601-2018-00553
- Event Type
- Malfunction
- Date Received
- September 10, 2018
- Date of Event
- August 17, 2018
- Report Date
- August 17, 2018
- Manufacturer
- PULSAR VASCULAR
- Product Code
- NJE
- PMA / PMN Number
- H160002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
MANUFACTURER¿S REF. NO: (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN WAS TREATING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM THAT HAS THE FOLLOWING SIZE AND CHARACTERISTICS: 5MM X 6MM WITH A 4MM NECK AND A SOMEWHAT SPHERICAL SHAPE WITH THE PULSERIDER DEVICE; THE PHYSICIAN WAS MADE AWARE IN ADVANCE THAT THIS WAS CONSIDERED AN OFF-LABEL USE FOR THE PULSERIDER DEVICE PER THE INDICATIONS FOR USE. THE PHYSICIAN ATTEMPTED TO TREAT THE ANEURYSM WITH TWO DIFFERENT PULSERIDER DEVICES. THE FIRST DEVICE WAS THE PULSERIDER T, 3MM, 8 MM ARCH (201D / W3218-02) WAS SUCCESSFULLY DEPLOYED BUT THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITIONING OF THE DEVICE. SHE MADE THE ATTEMPT TO RESHEATH THE PULSERIDER T DEVICE TO DEPLOY IT FOR POSITIONING DIFFERENCE. UPON THE ATTEMPT TO RESHEATH, THE DEVICE WOULD NOT FULLY CLOSE AND AS A RESULT, IT COULD NOT BE PROPERLY RESHEATHED. THE PHYSICIAN REMOVED THE PULSERIDER T DEVICE AND ON EXAMINING THE DEVICE, NOTICED THAT ONE OF THE LEAFLETS OF THE ARCH APPEARED TO BE STICKING IN A VERTICAL ORIENTATION IN COMPARISON TO THE REST OF THE LEAFLETS IN THE ARCH. A SECOND PULSERIDER Y, 3MM, 8 MM ARCH (301D / W3274-01) WAS USED WITH THE SAME MICROCATHETER AS THE FIRST PULSERIDER, THE PROWLER SELECT PLUS .021 STRAIGHT (606S255X / LOT # UNAVAILABLE), BUT THE SECOND DEVICE DID NOT FUNCTION PROPERLY. THE PULSERIDER DEVICE WAS DEPLOYED AND THE ARCHES WERE VISUALIZED ON WITH FLUOROSCOPY; THE DEVICE WAS TORQUED AFTER DEPLOYMENT TO PROPERLY ALIGN THE ARCHES. THERE WAS NO RESISTANCE BETWEEN THE PULSERIDER AND THE MICROCATHETER; A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. WHEN THE PHYSICIAN WAS DELIVERING THE SECOND DEVICE AND WHILE TRYING TO DEPLOY THE DEVICE, SHE MADE A COMMENT THAT SOMETHING DID NOT FEEL RIGHT, AND THE DEVICE WAS RECAPTURED INTO THE MICROCATHETER AND THE ENTIRE SYSTEM WAS REMOVED. UPON EXAMINING THE SECOND PULSERIDER DEVICE AFTER IT WAS REMOVED FROM THE PATIENT¿S ANATOMY, THE DEVICE WAS REPORTED TO BE TWISTED AND SOMEWHAT MANGLED IN APPEARANCE. THE PHYSICIAN NOTED AFTERWARDS THAT PERHAPS DUE TO THE SEVERE TORTUOSITY BELOW THE TARGET VESSEL, DOWN IN THE INTERNAL CAROTID ARTERY AND AORTIC ARCH MAY HAVE FACTORED INTO THE VECTORS OF THE MICROCATHETER AND AFFECTED THE ABILITY OF THE DEVICE TO TORQUE AND ROTATE EFFECTIVELY. THE PHYSICIAN DECIDED TO USE THE STANDARD COIL EMBOLIZATION PROCEDURE TO CONTINUE THE CASE WHICH WAS SUCCESSFULLY COMPLETED. THE REPORTED ISSUE WITH THE PULSERIDER DEVICES RESULTED IN A 35-40 MINUTES PROCEDURAL DELAY; APPROXIMATELY 15-20 MINUTE PER EACH DEVICE. THE DEVICES WERE EASILY REMOVED FROM THE PATIENT WITHOUT ANY INTERVENTION. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OF ADVERSE EVENT ASSOCIATED WITH THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT WAS DISCHARGED WITHIN 24 HOURS. THE PULSERIDER Y WAS RETURNED FOR EVALUATION AND TESTING. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE PULSERIDER Y AND THE CONCOMITANT MICROCATHETER WERE RETURNED IN THE SAME PACKAGE. THE UNITS WERE NOT LABELED, HOWEVER THE IMPLANT SHAPE OF THE DEVICE ALLOWED FOR ITS IDENTIFICATION. THE MICROCATHETER USED IN THE PROCEDURE WAS A PROWLER SELECT PLUS 2.8. NO KINKS OR DAMAGES WERE DISCOVERED ON THE MICROCATHETER. NO KINKED WERE OBSERVED ALONG THE DELIVERY WIRE OR INTRODUCER OF THE PULSERIDER Y. THE DEVICE WAS RETURNED WITH THE IMPLANT INSIDE THE DISTAL END OF THE INTRODUCER. SMALL PATCHES OF BLOOD WERE SEEN IN THE INTRODUCER. THE DEVICE WAS ADVANCED FROM THE INTRODUCER. A SINGLE LEAFLET WAS OBSERVED OUT OF SHAPE. THE CRIMP WAS SEEN INTACT; HOWEVER, THE ANCHOR STRUCTURE WAS OBSERVED TO BE BENT. THE ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WAS RETRACTED BACK INTO THE INTRODUCER, AND THE INTRODUCER WAS INSERTED INTO A LAB ROTATING HEMOSTATIC VALVE (RHV) ATTACHED TO THE RETURNED PROWLER SELECT PLUS MICROCATHETER. AN ATTEMPT WAS MADE TO ADVANCE THE DEVICE THROUGH THE MICROCATHETER. THE DEVICE WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER AS THE IMPLANT WAS IMPEDED AT THE MICROCATHETER ENTRANCE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT W3274-01 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. INVESTIGATION CONCLUSION: THE COMPLAINT OF ANRD DEPLOYMENT DIFFICULTY/INACCURATE PLACEMENT CANNOT BE CONFIRMED. THE PRODUCT ANALYSIS LAB CANNOT RECREATE THE PROCEDURAL STEPS THAT WERE PERFORMED. THE COMPLAINT OF ANRD DAMAGED - LEAFLETS IS CONFIRMED. THE PRODUCT WAS RETURNED WITH A LEAFLET BENT SO THAT IT WAS NOT ALIGNED WITH THE OTHER LEAFLETS. THE POSITIONING ISSUE MAY HAVE BEEN THE RESULT OF THE OUT OF SHAPE DEVICE. HOWEVER, THE COMPLAINT DESCRIPTION STATES THAT THE PHYSICIAN WAS MADE AWARE THAT THE PROCEDURE WAS OFF-LABEL PER INDICATIONS PER THE INSTRUCTION FOR USE (IFU). IT IS POSSIBLE THAT THE OFF-LABEL CONDITIONS CAUSED THE IMPLANT TO BE MISSHAPEN. THE PULSERIDER IMPLANT IS INSPECTED BEFORE LOADING THE DEVICE INTO PACKAGING. IT IS UNLIKELY THAT THE DEVICE LEFT MANUFACTURING WITH THE OBSERVED DAMAGE. DEPLOYMENT DIFFICULTY / INACCURATE PLACEMENT, DAMAGED LEAFLETS ARE KNOWN POTENTIAL ISSUES ASSOCIATED WITH THE USE OF THE PULSERIDER ANRD. WITH THE INFORMATION PROVIDED IN THE COMPLAINT, AND THE DEVICE RETURNED, THE ISSUE RELATED TO THE DEPLOYMENT DIFFICULTY / INACCURATE PLACEMENT WAS NOT CONFIRMED AS THE STEPS THAT WERE PERFORMED DURING THE PROCEDURE COULD NOT BE DUPLICATED. THE REPORTED ISSUE THAT THE PULSERIDER Y APPEARED TO BE TWISTED AND THE MANGLED APPEARANCE WAS CONFIRMED. ONE OF THE LEAFLETS ON THE DEVICE WAS BENT IN APPEARANCE AND OUT OF ALIGNMENT WITH THE OTHER LEAFLETS. THE TREATING PHYSICIAN DID NOTE THAT THE SEVERE VESSEL TORTUOSITY BELOW THE TARGET VESSEL IN THE INTERNAL CAROTID ARTERY AND THE AORTIC ARCH MAY HAVE FACTORED INTO THE VECTORS OF THE MICROCATHETER AND AS A RESULT, AFFECTED THE ABILITY OF THE DEVICE TO TORQUE AND ROTATE EFFECTIVELY. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE OFF-LABEL USE OF THE DEVICE WHICH PER THE IFU, IS INTENDED FOR USE FOR WITH EMBOLIC COILS FOR THE TREATMENT OF UNRUPTURED WIDE-NECKED INTRACRANIAL ANEURYSMS ORIGINATING ON OR NEAR A VESSEL BIFURCATION, CONTRIBUTED TO THE REPORTED ISSUES. THE PROCEDURE IN WHICH THE PULSERIDER Y DEVICE WAS USED WAS TO TREAT AN ACOM ANEURYSM WITH THE FOLLOWING SIZE AND CHARACTERISTICS: 5MM X 6MM WITH A 4MM NECK AND A SOMEWHAT SPHERICAL SHAPE. THE ANEURYSM SIZE, SEVERE VESSEL TORTUOSITY AND THE DEVICE SELECTION ARE ALSO LIKELY FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUES. IN ADDITION, THE PULSERIDER DEVICE IMPLANT IS INSPECTED FOR ANY DAMAGE BEFORE IT GETS LOADED INTO THE DEVICE INTO PACKAGING. IT IS UNLIKELY THAT THE DEVICE LEFT MANUFACTURING WITH THE OBSERVED DAMAGE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008680601-2018-00552 AND 3008680601-2018-00553. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
(B)(4). PRODUCT WAS RECEIVED AND IS PENDING EVALUATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT ONCE EVALUATION IS COMPLETED. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008680601-2018-00552 AND 3008680601-2018-00553. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
(B)(4). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008680601-2018-00552 AND 3008680601-2018-00553. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN WAS TREATING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM THAT HAS THE FOLLOWING SIZE AND CHARACTERISTICS: 5 MM X 6 MM WITH A 4 MM NECK AND A SOMEWHAT SPHERICAL SHAPE WITH THE PULSERIDER DEVICE; THE PHYSICIAN WAS MADE AWARE IN ADVANCE THAT THIS WAS CONSIDERED AN OFF-LABEL USE FOR THE PULSERIDER DEVICE PER THE INDICATIONS FOR USE. THE PHYSICIAN ATTEMPTED TO TREAT THE ANEURYSM WITH TWO DIFFERENT PULSERIDER DEVICES. THE FIRST DEVICE WAS THE PULSERIDER T, 3 MM, 8 MM ARCH (201D / W3218-02) WAS SUCCESSFULLY DEPLOYED BUT THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITIONING OF THE DEVICE. SHE MADE THE ATTEMPT TO RESHEATH THE PULSERIDER T DEVICE TO DEPLOY IT FOR POSITIONING DIFFERENCE. UPON THE ATTEMPT TO RESHEATH, THE DEVICE WOULD NOT FULLY CLOSE AND AS A RESULT, IT COULD NOT BE PROPERLY RESHEATHED. THE PHYSICIAN REMOVED THE PULSERIDER T DEVICE AND ON EXAMINING THE DEVICE, NOTICED THAT ONE OF THE LEAFLETS OF THE ARCH APPEARED TO BE STICKING IN A VERTICAL ORIENTATION IN COMPARISON TO THE REST OF THE LEAFLETS IN THE ARCH. A SECOND PULSERIDER (301D / W3274-01) WAS USED WITH THE SAME MICROCATHETER AS THE FIRST PULSERIDER, THE PROWLER SELECT PLUS .021 STRAIGHT (606S255X / LOT # UNAVAILABLE), BUT THE SECOND DEVICE DID NOT FUNCTION PROPERLY. THE PULSERIDER DEVICE WAS DEPLOYED AND THE ARCHES WERE VISUALIZED ON WITH FLUOROSCOPY; THE DEVICE WAS TORQUED AFTER DEPLOYMENT TO PROPERLY ALIGN THE ARCHES. THERE WAS NO RESISTANCE BETWEEN THE PULSERIDER AND THE MICROCATHETER; A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. WHEN THE PHYSICIAN WAS DELIVERING THE SECOND DEVICE AND WHILE TRYING TO DEPLOY THE DEVICE, SHE MADE A COMMENT THAT SOMETHING DID NOT FEEL RIGHT, AND THE DEVICE WAS RECAPTURED INTO THE MICROCATHETER AND THE ENTIRE SYSTEM WAS REMOVED. UPON EXAMINING THE SECOND PULSERIDER DEVICE AFTER IT WAS REMOVED FROM THE PATIENT¿S ANATOMY, THE DEVICE WAS REPORTED TO BE TWISTED AND SOMEWHAT MANGLED IN APPEARANCE. THE PHYSICIAN NOTED AFTERWARDS THAT PERHAPS DUE TO THE SEVERE TORTUOSITY BELOW THE TARGET VESSEL, DOWN IN THE INTERNAL CAROTID ARTERY AND AORTIC ARCH MAY HAVE FACTORED INTO THE VECTORS OF THE MICROCATHETER AND AFFECTED THE ABILITY OF THE DEVICE TO TORQUE AND ROTATE EFFECTIVELY. THE PHYSICIAN DECIDED TO USE THE STANDARD COIL EMBOLIZATION PROCEDURE TO CONTINUE THE CASE WHICH WAS SUCCESSFULLY COMPLETED. THE REPORTED ISSUE WITH THE PULSERIDER DEVICES RESULTED IN A 35-40 MINUTES PROCEDURAL DELAY; APPROXIMATELY 15-20 MINUTE PER EACH DEVICE. THE DEVICES WERE EASILY REMOVED FROM THE PATIENT WITHOUT ANY INTERVENTION. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OF ADVERSE EVENT ASSOCIATED WITH THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT WAS DISCHARGED WITHIN 24 HOURS. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703020 | PULSERIDER Y 3MM, 8MM ARCH | INTRACRANIAL NEUROVASCULAR STENT | NJE | PULSAR VASCULAR | W3274-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROWLER SELECT PLUS .021 STRAIGHT MICROCATHETER |