LIFESTREAM
Report
- Report Number
- 9616666-2017-00067
- Event Type
- Malfunction
- Date Received
- August 22, 2017
- Date of Event
- July 24, 2017
- Report Date
- October 4, 2017
- Manufacturer
- CLEARSTREAM TECHNOLOGIES LTD.
- Product Code
- PRL
- UDI-DI
- 05391522081468
- PMA / PMN Number
- P160024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. RECEIPT OF DEVICE IS PENDING. THE INVESTIGATION IS CURRENTLY IN PROGRESS. NOT RETURNED.
IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN A 6FR COOK ANSEL SHEATH DURING ADVANCEMENT INTO THE LESION. THE DOCTOR PREPPED THE DEVICE. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, TRAY OR STENT COVER AND NO DIFFICULTY REMOVING THE STENT COVER. THE PATIENT WAS BEING TREATED FOR SMA STENOSIS MESENTERIC ISCHEMIA. A 6F, 45CM ANSEL 2 INTRODUCER SHEATH AND A 0.035, 260CM ROSEN GUIDEWIRE WERE USED. THE DEVICE WAS ATTEMPTED TO BE INSERTED THROUGH THE 6F SHEATH HOWEVER RESISTANCE WAS FELT JUST PAST THE VALVE OF THE SHEATH. AN ATTEMPT WAS MADE TO RETRACT THE DEVICE FROM THE SHEATH HOWEVER THIS WAS UNSUCCESSFUL AS THE STENT WAS STUCK. THE STENT REMAINED STUCK IN THE INTRODUCER SHEATH. AIR EVACUATION WAS NOT PERFORMED PRIOR TO INSERTING THE DEVICE. MULTIPLE ATTEMPTS TO INSERT THE DEVICE WERE NOT MADE. THERE WAS NO REPORTED PATIENT INJURY. HOWEVER, THE ACCESS SITE WAS LOST. THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. NO MANUFACTURING ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE FIRST REPORTED COMPLAINT FOR THIS LOT NUMBER AND ISSUE TO DATE. THE DEVICE WAS RETURNED FOR EVALUATION. EXTERNAL PACKAGING WAS RETURNED. INTERNAL PACKAGING WAS NOT RETURNED. THE HUB WAS PRINTED AS EXPECTED AND THERE WERE NO VISUAL DEFECTS NOTED. THE STENT GUARD WAS NOT RETURNED. THERE WERE NO VISUAL DEFECTS NOTED ON THE TIP. NO VISUAL DEFECTS WERE NOTED ON THE SHAFT. THE DEVICE ARRIVED BACK WITH THE STENT CRIMPED IN THE CORRECT POSITION BETWEEN THE TWO MARKERBANDS. A FULL VISUAL INSPECTION OF THE BALLOON WAS NOT POSSIBLE AS THE STENT WAS STILL PRESENT. HOWEVER THERE WERE NO ISSUES NOTED ON THE AREA'S VISIBLE. A 6FR BLOODY SHEATH WAS RETURNED ATTACHED TO THE DEVICE. THERE WERE NO MARKINGS OR INDICATIONS OF THE MANUFACTURER ORIGIN. TOTAL LENGTH OF THE INTRODUCER SHEATH IS APPROX. 550MM. IT WAS NOTED THAT THE DEVICE WAS INSERTED APPROX. 175MM INTO THE RETURNED STENT. THE DEVICE WAS EASILY REMOVED FROM THE RETURNED SHEATH. AN EXTREMELY LARGE AMOUNT OF BLOOD WAS STILL PRESENT INSIDE OF THE DEVICE WHEN IT WAS RETURNED. AIR EVACUATION WAS PREFORMED PRIOR TO INSERTION INTO OUR OWN 6F INTRODUCER SHEATH. THE RETURNED DEVICE WAS INSERTED INTO OUR OWN 6F TERUMO SHEATH SUCCESSFULLY. THE DEVICE WAS THEN INSERTED INTO THE RETURNED SHEATH. THE DEVICE WAS INSERTED 140MM INTO THE 6FR SHEATH. SLIGHT RESISTANCE WAS FELT BEFORE THE DEVICE KINKED. ON REMOVAL OF THE DEVICE FROM THE SHEATH, A LARGE AMOUNT OF BLOOD WAS EXPELLED. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR IN CAUSING THE RESISTANCE AND THEN RESULTING KINK THE EVALUATION OF THE RETURNED DEVICE IS UNCONFIRMED FOR THE REPORTED FAILURE MODE OF DEVICE TO DEVICE INCOMPATIBILITY. THE DEVICE WAS SUCCESSFULLY INSERTED INTO OWN 6FR SHEATH. DUE TO THE CONDITION OF THE RETURNED SHEATH THE ATTEMPT TO INSERT THE DEVICE WAS UNSUCCESSFUL. USER ERROR MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE REPORTED EVENT AS AIR EVACUATION WAS NOT PERFORMED PRIOR TO INSERTING THE DEVICE INTO THE SHEATH. THE IFU, INDICATES DIRECTIONS FOR USE: SYSTEM PREPARATION - FLUSH THE DELIVERY SYSTEM GUIDEWIRE LUMEN WITH STERILE SALINE MIXTURE UNTIL SALINE DROPS FROM THE DISTAL END OF THE ENDOVASCULAR SYSTEM. AIR EVACUATION - (I) A 20CC OR SMALLER LUER-LOCK SYRINGE WITH A MINIMUM OF 54CC'S STERILE SALINE MIXTURE IS RECOMMENDED FOR USE FOR ASPIRATING THIS DEVICE. (II) WITH THE DISTAL BALLOON TIP POINTING DOWN AND POSITIONED BELOW THE LEVEL OF THE SYRINGE, PULL NEGATIVE PRESSURE UNTIL ALL AIR IS EXPELLED'. BASED UPON THE AVAILABLE INFORMATION AND SAMPLE EVALUATION A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. BASED ON ANALYSIS PERFORMED NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. NOTE: WHILE THE CURRENT CONFIRMED CALCULATED RATE FOR THIS FAILURE MODE IS 0.065% (LAST 24 MONTHS) AND IS HENCE HIGHER THAN THE PREDICTED RATE OF 0.02%, THE RATE IS DECREASING SINCE THE PROCESS IMPROVEMENT (ACTION FROM CAPA) WAS INTRODUCED INTO PRODUCTION DURING SEPT 16. THE CONFIRMED RATE FROM SEPT 16 TO AUG 17 IS 0.02%. THIS IS EQUAL TO THE PREDICTED RATE OF 0.02% THE IFU STATES: A DEVICE DESCRIPTION IMPLANT THE LIFESTREAM¿ BALLOON EXPANDABLE VASCULAR COVERED STENT IS COMPRISED OF AN ELECTROPOLISHED BALLOON-EXPANDABLE STENT MADE FROM 316L STAINLESS STEEL, ENCAPSULATED BETWEEN TWO LAYERS OF EPTFE. INDICATION FOR USE THE LIFESTREAM¿ BALLOON EXPANDABLE VASCULAR COVERED STENT IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS IN COMMON AND EXTERNAL ILIAC ARTERIES. DIRECTIONS FOR USE: SITE ACCESS AND PREPARATION USING STANDARD TECHNIQUES ACCESS THE ARTERY AND PLACE AN INTRODUCER SHEATH OR GUIDING CATHETER OF APPROPRIATE INNER DIAMETER AND A 0.035" (0.89 MM) GUIDEWIRE ACROSS THE TARGET LESION. PERFORM DIAGNOSTIC ANGIOGRAPHY TO CONFIRM SITE OF IMPLANTATION AND MEASURE THE REFERENCE VESSEL DIAMETER AND LESION LENGTH. COVERED STENT SIZE SELECTION SELECT A COVERED STENT DIAMETER THAT IS APPROXIMATELY 5%-20% LARGER THAN THE LARGEST REFERENCE VESSEL DIAMETER AT THE PROXIMAL OR DISTAL TARGET SITE. REFER TO THE SIZING TABLE ON THE PACKAGING LABEL FOR APPROPRIATE SELECTION OF THE COVERED STENT DIAMETER AND LENGTH. ENDOVASCULAR SYSTEM PREPARATION CAREFULLY REMOVE THE SELECTED DEVICE FROM THE PACKAGE. INSPECT THE COVERED STENT FOR ADHERENCE TO THE BALLOON AND CENTERED PLACEMENT IN RELATION TO THE BALLOON MARKER BANDS. IF THE COVERED STENT IS NOT CENTERED AND/OR DOES NOT FIRMLY ADHERE TO THE BALLOON, DO NOT USE. FLUSH THE DELIVERY SYSTEM GUIDEWIRE LUMEN WITH STERILE SALINE MIXTURE UNTIL SALINE DROPS FROM THE DISTAL END OF THE ENDOVASCULAR SYSTEM. AIR EVACUATION A 20 CC OR SMALLER LUER-LOCK SYRINGE WITH A MINIMUM OF 5 CC¿S STERILE SALINE MIXTURE IS RECOMMENDED FOR USE FOR ASPIRATING THIS DEVICE. WITH THE DISTAL BALLOON TIP POINTING DOWN AND POSITIONED BELOW THE LEVEL OF THE SYRINGE, PULL NEGATIVE PRESSURE UNTIL ALL AIR IS EXPELLED. INDUCE A NEGATIVE PRESSURE TO REMOVE ANY AIR FROM THE BALLOON AND INFLATION LUMEN. REPEAT UNTIL ALL AIR IS EXPELLED. CAREFULLY RELEASE TO NEUTRAL. ALLOW THE INFLATION LUMEN TO FILL WITH THE DILUTED CONTRAST MEDIUM AND MAINTAIN A NEUTRAL PRESSURE. IMPORTANT: DO NOT APPLY POSITIVE PRESSURE TO THE BALLOON. ATTACH THE PREFILLED INFLATION DEVICE TO THE INFLATION LUMEN OF THE CATHETER HUB, ENSURING NO AIR BUBBLES REMAIN AT THE CATHETER CONNECTION. VERIFY THAT THE COVERED STENT IS STILL CENTERED BETWEEN THE TWO RADIOPAQUE MARKERS ON THE BALLOON CATHETER. INTRODUCTION OF THE ENDOVASCULAR SYSTEM AND PLACEMENT OF THE COVERED STENT ADVANCE THE ENDOVASCULAR SYSTEM OVER THE GUIDEWIRE INTO THE INTRODUCER SHEATH. FURTHER ADVANCE THE ENDOVASCULAR SYSTEM TO THE TARGET TREATMENT SITE WITHIN THE INTRODUCER SHEATH AND POSITION THE COVERED STENT ACROSS THE LESION. VERIFY THAT THE COVERED STENT IS STILL CENTERED WITHIN THE BALLOON MARKER BANDS. SLOWLY RETRACT THE INTRODUCER SHEATH / GUIDING CATHETER WHILE MAINTAINING THE POSITION OF THE COVERED STENT. ENSURE THE INTRODUCER SHEATH IS RETRACTED FAR ENOUGH TO NOT COMPROMISE THE BALLOON EXPANSION AND COVERED STENT RELEASE. (B)(4).
IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN A 6FR COOK ANSEL SHEATH DURING ADVANCEMENT INTO THE LESION. THE DOCTOR PREPPED THE DEVICE. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, TRAY OR STENT COVER AND NO DIFFICULTY REMOVING THE STENT COVER. THE PATIENT WAS BEING TREATED FOR SMA STENOSIS MESENTERIC ISCHEMIA. A 6F, 45CM ANSEL 2 INTRODUCER SHEATH AND A 0.035, 260CM ROSEN GUIDEWIRE WERE USED. THE DEVICE WAS ATTEMPTED TO BE INSERTED THROUGH THE 6F SHEATH HOWEVER RESISTANCE WAS FELT JUST PAST THE VALVE OF THE SHEATH. AN ATTEMPT WAS MADE TO RETRACT THE DEVICE FROM THE SHEATH HOWEVER THIS WAS UNSUCCESSFUL AS THE STENT WAS STUCK. THE STENT REMAINED STUCK IN THE INTRODUCER SHEATH. AIR EVACUATION WAS NOT PERFORMED PRIOR TO INSERTING THE DEVICE. MULTIPLE ATTEMPTS TO INSERT THE DEVICE WERE NOT MADE. THERE WAS NO REPORTED PATIENT INJURY. HOWEVER, THE ACCESS SITE WAS LOST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589660 | LIFESTREAM | BALLOON EPANDABLE VASCULAR COVERED STENT | PRL | CLEARSTREAM TECHNOLOGIES LTD. | LSMU1350616 | CMBP0065 | 05391522081468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |