CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2011-00082
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- December 10, 2010
- Report Date
- December 20, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE ENGINEERING ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A PCI, AFTER DEPLOYMENT OF TWO CYPHER STENTS IN THE PROXIMAL RCA, THE PHYSICIAN EXPERIENCED DIFFICULTY TRACKING A THIRD CYPHER STENT THROUGH THE PREVIOUSLY DEPLOYED STENTS. THE STENT WAS FINALLY DEPLOYED IN THE MID RCA, A NON-INTENDED TARGET SITE. INITIALLY, THE PHYSICIAN IMPLANTED A 3.5X28MM AND A 3.0X23MM CYPHER SELECT + STENTS IN A LESION IN THE PROXIMAL RCA. THE VESSEL WAS 70-80% AND CALCIFIED. THEN, A 3.0X33 CYPHER SELECT + WAS ADVANCED AND INTENDED TO BE IMPLANTED IN A LESION LOCATED IN THE DISTAL RCA.. HOWEVER, THE STENT "ENCOUNTERED FRICTION AND COULD NOT CROSS THROUGH THE PREVIOUS 2 DEPLOYED STENTS, SO THE PHYSICIAN DEPLOYED THE STENT IN THE MIDDLE TO DISTAL RCA." THE DISTAL LESION WAS TREATED WITH ANOTHER PRODUCT SUCCESSFULLY. IT WAS UNKNOWN IF PRE AND POST-DILATION WAS CONDUCTED. THE REPORTER INDICATED THAT THE PHYSICIAN HAD THE HABIT OF TREATING PROXIMAL LESIONS BEFORE DISTAL LESIONS. THE IFU INDICATES THAT WHEN TREATING MULTIPLE LESIONS, THE DISTAL LESION SHOULD BE INITIALLY STENTED, FOLLOWED BY STENTING OF THE PROXIMAL LESION. STENTING IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT IN PLACEMENT OF THE DISTAL STENT. ONE NON-STERILE CYPHER SELECT + 3.00 X 33MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS NOT RECEIVED; CRIMPING AND BUMPING MARKS WERE OBSERVED IN THE BALLOON. RESIDUES OF INFLATION MEDIUM WERE OBSERVED. BENDS WERE OBSERVED AT 27.5, 29, 44, 50 AND 78 CM FROM DISTAL END. THE CROSSING PROFILE WAS NOT PERFORMED, BECAUSE THE STENT WAS NOT RECEIVED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE EXACT CAUSE OF THE FAILURES EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED BUT THEY DO NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE VESSEL FACTORS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE TRACKING DIFFICULTY EXPERIENCED DELIVERING THE PRODUCT THROUGH TWO PREVIOUSLY DEPLOYED STENTS RESULTING IN IMPLANTATION OF THE STENT AT THE UNINTENDED SITE. NEITHER THE PRODUCT ANALYSIS NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.
STENT CROSSING DIFFICULTY: THE STENT (CYPHER SELECT + 3.00X33MM) COULD CROSS NOT THROUGH THE LESION WITH TORTUOUS, 70% STENOSIS AND CALCIFIED. THE PHYSICIAN SUCCESS WHEN SHE CHANGED THE OTHER STENT. THE STENT WILL BE RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION RECEIVED 1/11/2011: THE PATIENT WAS TREATED WITH 2 STENTS IN THE RCA PREVIOUSLY, THE CORDIS STENT COULD NOT CROSS THROUGH THE 2ND STENT, SO THE PHYSICIAN JUST DEPLOYED CORDIS STENT AT MIDDLE-TO-DISTAL RCA. ADDITIONAL INFORMATION RECEIVED: 1/28/2011: THE TARGET LESION WAS CONFIRMED AS THE RCA. THE PREVIOUS TWO STENTS WERE BOTH CORDIS CYPHER SELECT PLUS STENTS (CRB28350 AND CRB23300). THE TARGET LESION WAS NOT WITHIN 5MM OF THESE STENTS. THE VESSEL WAS 70-80% CALCIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | NA | 15163434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |