ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2019-00245
- Event Type
- Malfunction
- Date Received
- June 6, 2019
- Date of Event
- March 20, 2019
- Report Date
- July 4, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002519296
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- 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)(6). COOK MEDICAL INCORPORATED (CMI) (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 SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION THE ZFV6-80-10-4.0 DEVICE OF LOT NUMBER C1482121 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 10MAY2019. THE STENT WAS PARTIALLY DEPLOYED ON RETURN (RED TAB IN). TIP HAD NO DAMAGE AND NO KINKS ON DELIVERY SYSTEM. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZFV6-80-10-4.0 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 RELEVANT MANUFACTURING RECORDS (C1482121) 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 C1482121. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO COMPRESSION OF THE FLEXOR DURING ADVANCEMENT OF THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. 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.
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.
DEVICE WAS GOING TO BE USED ON A PATIENT FOR A VASCULAR ANGIOPLASTY. THE CONSULTANT RADIOLOGIST FLUSHED THE STENT AND ATTEMPTED TO INSERT IT INTO THE SHEATH AND WAS UNABLE TO EXTEND IT AS THE TIP WAS BROKEN. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NONE. "AS PER COMPLAINT FORM": PHYSICIAN COULD NOT ADVANCE SYSTEM THROUGH THE SHEATH.
DEVICE WAS GOING TO BE USED ON A PATIENT FOR A VASCULAR ANGIOPLASTY. THE CONSULTANT RADIOLOGIST FLUSHED THE STENT AND ATTEMPTED TO INSERT IT INTO THE SHEATH AND WAS UNABLE TO EXTEND IT AS THE TIP WAS BROKEN. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NONE. "AS PER COMPLAINT FORM": PHYSICIAN COULD NOT ADVANCE SYSTEM THROUGH THE SHEATH.
DEVICE WAS GOING TO BE USED ON A PATIENT FOR A VASCULAR ANGIOPLASTY. THE CONSULTANT RADIOLOGIST FLUSHED THE STENT AND ATTEMPTED TO INSERT IT INTO THE SHEATH AND WAS UNABLE TO EXTEND IT AS THE TIP WAS BROKEN. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NONE. "AS PER COMPLAINT FORM": PHYSICIAN COULD NOT ADVANCE SYSTEM THROUGH THE SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469626 | ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | C1482121 | 10827002519296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |