ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

Report

Report Number: 3001845648-2020-00001
Event Type: Malfunction
Date Received: January 2, 2020
Date of Event: October 16, 2019
Report Date: March 26, 2020
Manufacturer: COOK IRELAND LTD
Product Code: NIO
UDI-DI: 10827002528502
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

PMA/510(K)#: P050017/S006. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A-DEVICE DID NOT RETURN. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZFV6 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE LOT COULD NOT BE COMPLETE AS THE LOT# IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0058-4). IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER . AN ADDITIONAL PR ((B)(4)) WAS OPENED FOR THE "STRETCHING OF MIDDLE STENT, LIKELY A ZILVER STENT" NOTED IN THE IMAGE REVIEW. IMPRESSION: 1. INABILITY TO RELEASE THE COMPLAINT STENT CANNOT BE CONFIRMED AS IMAGING OF THE EVENT WAS NOT PROVIDED. GIVEN THE COMPLAINT REPORT DETAILS AND THE PROVIDED IMAGING, INABILITY TO ADVANCE THE STENT DELIVERY SYSTEM INTO THE INTENDED IMPLANTATION SITE IS LIKELY A BETTER INTERPRETATION OF THE COMPLAINT. 2. ULTIMATELY, THE MID SFA WAS STENTED FIRST. THIS STENT WAS MOST CONSISTENT WITH A VERY STRETCHED ZILVER STENT. THE PROXIMAL SFA WAS THEN STENTED WITH MOST LIKELY THE ASTRON PULSAR STENT. THE STENTED VESSEL LIKELY FACILITATED INNOVA STENT DELIVERY TO THE PA. 3. STRETCHING OF MIDDLE STENT, LIKELY A ZILVER STENT, IS MOST INDICATIVE OF SIGNIFICANT FRICTION THROUGH THE ILIAC ARTERIES. THE SPIRALING, SEVERELY CALCIFIED, AND LONG DISTAL SFA SUBINTIMAL CHANNEL WOULD HAVE ADDED EVEN ADDITIONAL RESISTANCE TO DELIVERY SYSTEM ADVANCEMENT INTO THE PA. 4. THE MOST LIKELY CLINICAL SCENARIO WAS AN INITIAL INTENTION TO STENT A 32CM LONG SEGMENT WITH TWO 17CM LONG ZILVER STENTS. WHEN THE ZFV6-125-5- 17.0 WOULD NOT ADVANCE INTO THE PA, THE PLAN WAS AMENDED TO FIRST STENTING THE MID AND PROXIMAL SFA. THE PA WAS THEN REACHED USING THE IMPLANTED STENTS AS A CONDUIT. GIVEN THAT PULSAR STENT WAS SIX RATHER THAN FIVE MILLIMETERS, THE SITE¿S AVAILABLE INVENTORY OF LENGTHS AND DIAMETERS ALSO LIKELY PLAYED ROLE IN WHICH STENTS WERE PLACED WHERE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO TORTUOUS AND CALCIFIED ANATOMY. AS PER IMAGING REVIEW ¿STRETCHING OF MIDDLE STENT, LIKELY A ZILVER STENT, IS MOST INDICATIVE OF SIGNIFICANT FRICTION THROUGH THE ILIAC ARTERIES.¿ THIS FRICTION THROUGH THE ILIAC ARTERIES MAY HAVE COMPRESSED THE FLEXOR, POSSIBLY CAUSED DIFFICULTY ADVANCING THE DEVICE RESULTING IN THE STENT STRETCHING. AS PER IMAGING REVIEW: ¿INABILITY TO ADVANCE THE STENT DELIVERY SYSTEM INTO THE INTENDED IMPLANTATION SITE IS LIKELY A BETTER INTERPRETATION OF THE COMPLAINT.¿ IN RELATION TO THE ISSUE OF DEPLOYMENT WITH THE FIRST DEVICE UNDER (B)(4). AS THE INITIAL INTENDED TARGET SITE PROVED DIFFICULT TO REACH THE STENTING APPROACH WAS AMENDED AS THE ORIGINAL TARGET SITE COULD NOT BE REACHED. ¿THE MOST LIKELY CLINICAL SCENARIO WAS AN INITIAL INTENTION TO STENT A 32CM LONG SEGMENT WITH TWO 17CM LONG ZILVER STENTS. WHEN THE ZFV6-125-5-17.0 WOULD NOT ADVANCE INTO THE PA, THE PLAN WAS AMENDED TO FIRST STENTING THE MID AND PROXIMAL SFA. THE PA WAS THEN REACHED USING THE IMPLANTED STENTS AS A CONDUIT.¿ (B)(4) DEALS WITH THE STENT PLACED ¿INTO THE SEVERELY CALCIFIED MID TO DISTAL SFA AND PA SEGMENT.¿ ANOTHER STENT ¿PULSAR ASTRON 6X150MM STENT WAS LIKELY THEN IMPLANTED FROM THE SFA ORIGIN INTO THE SUPERIOR END OF THE FIRST STENT.¿ SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

Description of Event or Problem · 0

IMAGING REVIEW: ULTIMATELY, THE MID SFA WAS STENTED FIRST. THIS STENT WAS MOST CONSISTENT WITH A VERY STRETCHED ZILVER STENT. STRETCHING OF MIDDLE STENT, LIKELY A ZILVER STENT, IS MOST INDICATIVE OF SIGNIFICANT FRICTION THROUGH THE ILIAC ARTERIES. THE DATE AWARE IS THE 06DEC2019 WHICH IS THE DATE WE RECEIVED THE IMAGE REVIEW BACK. ZIV6/ZFV6: 1. WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT DEVICE? SFA AND POPLITEAL. 2. WAS THE DEVICE USED PERCUTANEOUSLY? YES. 3. WHICH ARTERY WAS THE STENT TO BE PLACED IN? SFA AND POPLITEAL (FULL METAL JACKET). 4. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? CROSSOVER. 5. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE TIGHT? YES A LITTLE. 6. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? FEMORAL PUNCTURE SITE. 7. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6 F INTRODUCER CORDIS AVANTI+. 8. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? 9. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? TERUMO STIFF NAVI CROSS. 10. WAS THE PATIENT'S ANATOMY TORTUOUS OR CALCIFIED? YES. 11. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR DELIVERY SYSTEM TO THE TARGET LOCATION? HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? YES A LOT OF FRICTION. HE TRIED TO GO AHEAD BUT AT THE END IT TAKES THE DEVICE OFF, AND IT WAS REPLACED WITH A INNOVA 5X100, SO THE PATIENT HAD A PULSAR ASTRON 6X150 FOLLOW A ZILVER 5X100 AND FOLLOW (POPLITEAL) A INNOVA 5X100 ( INSTEAD OF 2 ZILVER). 12. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES SENRI BALLOON. 13. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? YES BUT NOT THE STENT COMPLAINED. 14. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? NO. 15. ARE IMAGES OF THE DEVICE OF PROCEDURE AVAILABLE? YES BUT ONLY PROCEDURE. 16. DID THE USER PULL THE HANDLE TOWARD THE HUB DURING DEPLOYMENT AND DELIVERY SYSTEM WAS NOT PUSHED DURING DEPLOYMENT? NO. 17. WHAT ARTERY WAS THE STENT PLACED IN? LEFT SFA. 18. IS THE DEVICE GOING TO BE RETURNED? PLEASE PROVIDE THE TRACKING NUMBER, YES. I¿M TRYING TO SEND BACK, THEY HAVE IN A PHARMACY OUTSIDE OF THE HOSPITAL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative · 1

PMA/510(K) #: P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem · 1

(B)(4) IMAGING REVIEW: ULTIMATELY, THE MID SFA WAS STENTED FIRST. THIS STENT WAS MOST CONSISTENT WITH A VERY STRETCHED ZILVER STENT. STRETCHING OF MIDDLE STENT, LIKELY A ZILVER STENT, IS MOST INDICATIVE OF SIGNIFICANT FRICTION THROUGH THE ILIAC ARTERIES. THE DATE AWARE IS THE 06DEC2019 WHICH IS THE DATE WE RECEIVED THE IMAGE REVIEW BACK. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT ELONGATION". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
546	ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT	NIO STENT, ILIAC	NIO	COOK IRELAND LTD		C1611608	10827002528502

Patients

Seq	Age	Sex	Outcome	Treatment
1