ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2018-00328
- Event Type
- Injury
- Date Received
- July 23, 2018
- Date of Event
- June 25, 2018
- Report Date
- September 17, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002518787
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K) #= P050017/S006. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) #= P050017/S006 COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K)#: P050017/S006. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)(4). PROBLEM STATEMENT: "DURING STENT'S DEPLOYMENT, AS THE STENT WAS RELEASED, IT JUMPED PROXIMALLY INTO AORTA. WHILST ATTEMPTING TO PULL THE STENT BACK, IT GOT ELONGATED AT THE SIZE OF LESION. PART OF PROXIMAL EDGE OF THE STENT GOT ACCIDENTALLY DEPLOYED IN THE FEMORAL SHEATH." DEVICE EVALUATION: THE ZFV6-125-8-14.0 DEVICE OF LOT NUMBER: C1194949 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION DESPITE SEVERAL REQUESTS FROM CIRL. THE INVESTIGATION WILL BE UPDATED IN THE FUTURE SHOULD THE DEVICE BE RETURNED TO CIRL. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT TARGET LOCATION FOR THE DEVICE WAS IN THE COMMON ILIAC ARTERY (CIA). THE DEVICE WAS USED PERCUTANEOUSLY, VIA AN IPSILATERAL APPROACH. THE COMPLAINT DEVICE WAS ADVANCED THROUGH A MEDTRONIC 7FR SHEATH, OVER A 0.035¿ DIAMETER TERUMO HYDROPHILIC WIRE GUIDE. THE PATIENT¿S ANATOMY WAS CALCIFIED. PRE-DILATION WAS CONDUCTED PRIOR TO STENT DEPLOYMENT, BUT POST-DEPLOYMENT WAS NOT CONDUCTED. THE TIP OF THE DELIVERY SYSTEM CROSSED THE TARGET LESION, AND THE DELIVERY SYSTEM WAS NOT PUSHED DURING DEPLOYMENT. FROM THE INFORMATION PROVIDED IT WAS CONFIRMED THAT THE HUB WAS PULLED DURING DEPLOYMENT OF THE STENT. THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE DELIVERY SHEATH POSSIBLY CAUSING THE STENT TO ELONGATE. THE CUSTOMER CONFIRMED THAT ¿FEMORAL SHEATH¿ REFERS TO THE FEMORAL INTRODUCER SHEATH. THE STENT PARTIALLY DEPLOYED IN THE CIA. THERE WAS NO RUPTURE OR PERFORATION OF VESSELS AND IMAGES ARE NOT AVAILABLE FROM THIS PROCEDURE. ADDITIONAL INFORMATION REGARDING THE JUMPING OF THE STENT WAS ALSO REQUESTED FROM THE CUSTOMER HOWEVER, AT THE TIME OF THE INVESTIGATION A RESPONSE HAD NOT BEEN RECEIVED. THE INVESTIGATION WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE TO CIRL. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. A POSSIBLE ROOT CAUSE FOR THIS COMPLAINT IS THE USER PULLING THE HUB OF THE DEVICE DURING DEPLOYMENT. PULLING THE HUB OF THE DEVICE COULD HAVE RESULTED IN THE STENT JUMPING DURING DEPLOYMENT. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT CAN BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING; ¿HOLD THE HUB (B) ON THE METAL CANNULA (G) STEADY. TO DEPLOY THE STENT, REMOVE THE RED SAFETY LOCK (C). HOLD THE HUB END STATIONARY. THE STENT WILL BE DEPLOYED AS YOU PULL THE HANDLE (A) TOWARD THE HUB (B).¿ ¿AS DEPLOYMENT OCCURS, CONTINUE SLIDING THE HANDLE (A) TOWARD THE HUB (B) IN A SLOW, SMOOTH AND CONSISTENT FASHION. NOTE: ONCE STENT DEPLOYMENT HAS BEGUN, THE STENT MUST BE FULLY DEPLOYED. REPOSITIONING OF THE ZILVER FLEX 35 VASCULAR STENT IS NOT POSSIBLE SINCE THE DELIVERY SYSTEM¿S OUTER SHEATH CANNOT BE RE-ADVANCED OVER THE STENT ONCE DEPLOYMENT BEINGS. REFER TO THE MULTIPLE STENT PLACEMENT SECTION OF THESE INSTRUCTIONS FOR USE FOR INFORMATION ON MISSED LESIONS.¿ DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER FLEX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY: ¿CHECK FOR THE PRESENCE OF THE STENT UNDER THE FLEXOR USING A NIKON MICROSCOPE SET AT POSITION 3 WHICH EQUATES TO 30X MAGNIFICATION." STEP 15 " CHECK FOR THE PRESENCE OF 8 GOLD RIVETS PER STENT UNDER THE FLEXOR USING A NIKON MICROSCOPE SET AT POSITION 3 WHICH EQUATES TO 30X MAGNIFICATION.¿ A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1194949) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER: C1194949. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK FOR THIS COMPLAINT IS RISK CATEGORY IIA/LOW RISK. 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.
DURING STENT'S DEPLOYMENT, AS THE STENT WAS RELEASED, IT JUMPED PROXIMALLY INTO AORTA. WHILST ATTEMPTING TO PULL THE STENT BACK, IT GOT ELONGATED AT THE SIZE OF LESION. PART OF PROXIMAL EDGE OF THE STENT GOT ACCIDENTALLY DEPLOYED IN THE FEMORAL SHEATH.
REPORT IS SUBMITTED AS SURGICAL INTERVENTION WAS REQUIRED, ALSO UNDER THE REPORTING PRECEDENCE "STENT ELONGATES". DURING STENT'S DEPLOYMENT, AS THE STENT WAS RELEASED, IT JUMPED PROXIMALLY INTO AORTA. WHILST ATTEMPTING TO PULL THE STENT BACK, IT GOT ELONGATED AT THE SIZE OF LESION. PART OF PROXIMAL EDGE OF THE STENT GOT ACCIDENTALLY DEPLOYED IN THE FEMORAL SHEATH.
REPORT IS SUBMITTED AS SURGICAL INTERVENTION WAS REQUIRED, ALSO UNDER THE REPORTING PRECEDENCE "STENT ELONGATES". DURING STENT'S DEPLOYMENT, AS THE STENT WAS RELEASED, IT JUMPED PROXIMALLY INTO AORTA. WHILST ATTEMPTING TO PULL THE STENT BACK, IT GOT ELONGATED AT THE SIZE OF LESION. PART OF PROXIMAL EDGE OF THE STENT GOT ACCIDENTALLY DEPLOYED IN THE FEMORAL SHEATH.
PMA/510(K) #= P050017/S006. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
REPORT IS SUBMITTED AS SURGICAL INTERVENTION WAS REQUIRED, ALSO UNDER THE REPORTING PRECEDENCE "STENT ELONGATES". DURING STENT'S DEPLOYMENT, AS THE STENT WAS RELEASED, IT JUMPED PROXIMALLY INTO AORTA. WHILST ATTEMPTING TO PULL THE STENT BACK, IT GOT ELONGATED AT THE SIZE OF LESION. PART OF PROXIMAL EDGE OF THE STENT GOT ACCIDENTALLY DEPLOYED IN THE FEMORAL SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 552776 | ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | C1194949 | 10827002518787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |