CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00378
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- November 8, 2010
- Report Date
- December 10, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT STUDY EXPERIENCED IN-STENT ANEURYSM, STENT FRACTURE AND SIDE BRANCH OCCLUSION AFTER THE IMPLANTATION OF THREE CYPHER STENTS. HIS MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS PCI, PREVIOUS CABG, HYPERLIPIDEMIA, AND HYPERTENSION. AT THE TIME OF THE INDEX PROCEDURE, LESIONS IN THE PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA) WERE TREATED. THE DISTAL RCA LESION WAS 95% STENOSED AND 18MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 8ATM AND A 3.5 X 23MM CYPHER RX WAS IMPLANTED AT 11ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 12MM BALLOON AT 8ATM. THE CRF INDICATED THAT PRE-INDEX PROCEDURE, THE R PDA SHOWED 15% STENOSIS, BUT THERE WAS 60% STENOSIS POST STENTING OF THE DISTAL RCA. IT WAS PREVIOUSLY REPORTED THAT THE R PDA WAS TREATED WITH BALLOON ANGIOPLASTY DURING THE INDEX PROCEDURE. THE MID RCA LESION WAS 80% STENOSED, DE NOVO, AND 30MM IN LENGTH. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 10ATM AND A 3.5 X 33 CYPHER RX WAS IMPLANTED AT 11ATM. THE STENT WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.0 X 12MM BALLOON AT 10ATM. ANGIOGRAPHY REVEALED 60% STENOSIS IN THE PROXIMAL RCA. THE LESION WAS DE NOVO AND 15MM IN LENGTH. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 8ATM AND A 3.0 X 23MM CYPHER RX WAS IMPLANTED AT 14ATM WITH NO POST-DILATION. PRE AND POST TIMI FLOW WAS 3 FOR ALL AND THERE WAS NO RESIDUAL STENOSIS FOR ALL STENTS. AT THE 30-DAY VISIT, THE PATIENT REPORTED EXPERIENCED ANGINA, BUT NO ADVERSE EVENTS OR TREATMENT WAS REPORTED. AT THE SIX MONTH VISIT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSTABLE ANGINA, BUT NO TREATMENT OR TESTING WAS REPORTED. IT WAS REPORTED THAT THE CHEST PAIN AT THE 30-DAY AND SIX MONTH VISITS MAY HAVE BEEN RELATED TO PRE-EXISTING AORTITIS (VASCULITIS). EIGHT MONTHS AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSTABLE ANGINA. ANGIOGRAPHY REVEALED NEW LESIONS IN THE PROXIMAL AND MID CIRCUMFLEX ARTERIES, NON-TARGET VESSELS THAT WERE TREATED WITH PROMUS STENTS AND A LESION IN THE FIRST OBTUSE MARGINAL THAT WAS TREATED WITH BALLOON ANGIOPLASTY. ADDITIONALLY, AT THIS TIME, PERI-STENT ANEURYSM WAS NOTED AROUND THE MID AND PROXIMAL RCA STENTS THAT HAD BEEN IMPLANTED IN THE RCA DURING THE INDEX PROCEDURE. THE ANEURYSMS WERE NOT FLOW LIMITING AND THERE WAS NO TREATMENT PLANNED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ANGIOGRAPHIC CORE LABORATORY INDICATING THAT THERE WAS A TRANSVERSE STENT FRACTURE WITH ABUNDANT MOVEMENT AND DISPLACEMENT OF FRACTURE FRAGMENTS OF MORE THAN 1MM DURING CARDIAC CYCLE IN THE MID RCA STENT. THE PROXIMAL RCA STENT OVERLAPPED THE MID RCA STENT IN ITS PROXIMAL EDGE, BUT THE STENT FRACTURE DID NOT OCCUR IN THE AREA OF OVERLAP. THE FRACTURE WAS ASSOCIATED WITH ANEURYSMIC DILATION. IT WAS REPORTED THAT THE LESION HAD A 75% DEGREE BEND AT THE TIME OF STENT IMPLANTATION AND WAS LOCATED AT THE BIFURCATION OF THE AC MARGINAL. THERE WAS NO REPORTED TREATMENT FOR THE FRACTURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE EXACT MECHANISM FOR ANEURYSM FORMATION AND STENT FRACTURE AFTER DES IMPLANTATION IS STILL UNCLEAR. CORONARY ARTERY ANEURYSM IS DEFINED AS CORONARY DILATATION WHICH EXCEEDS THE DIAMETER OF NORMAL ADJACENT SEGMENTS OR THE DIAMETER OF THE PATIENT'S LARGEST CORONARY VESSEL BY 1.5 TIMES. EXCESSIVE DILATION MAY CAUSE DEEP WALL INJURY OF THE VESSEL THAT MAY LEAD TO ANEURYSM AND OR STENT FRACTURE FINDINGS. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. TYPICALLY THE RIGHT CORONARY ARTERY (RCA) HAS MORE MOTION THAN OTHER CORONARY ARTERIES. LONGER STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. SIDE BRANCH OCCLUSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. CORONARY VASCULATURE THAT IS IN A BIFURCATION, TORTUOUS, CALCIFIED AND ANGULATED IS OFTEN A PRECURSOR TO THE INABILITY TO MAINTAIN SIDE BRANCH PATENCY ONCE THE MAIN BRANCH IS STENTED. THE ACT OF CORONARY STENTING IN A BIFURCATION IS ASSOCIATED WITH A LOW SUCCESS RATE, HIGH RATE OF COMPLICATIONS AND A HIGH INCIDENCE OF TARGET VESSEL REVASCULARIZATION. HOWEVER, PROCEDURAL, PATIENT, AND VESSEL/LESION CHARACTERISTICS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00010, 3003742446-2011-00011 AND 3003742446-2011-00378.
THE MID RCA LESION WAS 80% STENOSED, DE NOVO, AND 30MM IN LENGTH. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 10ATM AND A 3.5 X 33 CYPHER RX WAS IMPLANTED AT 11ATM. THE STENT WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.0 X 12MM BALLOON AT 10ATM. ANGIOGRAPHY REVEALED 60% STENOSIS IN THE PROXIMAL RCA. THE LESION WAS DE NOVO AND 15MM IN LENGTH. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 8ATM AND A 3.0 X 23MM CYPHER RX WAS IMPLANTED AT 14ATM WITH NO POST-DILATION. PRE AND POST TIMI FLOW WAS 3 FOR ALL AND THERE WAS NO RESIDUAL STENOSIS FOR ALL STENTS. THERE WERE NO POST-PROCEDURE CARDIAC ENZYME ELEVATIONS. EIGHT MONTHS AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSTABLE ANGINA. ANGIOGRAPHY REVEALED NEW LESIONS IN THE PROXIMAL AND MID CIRCUMFLEX ARTERIES (NON-TARGET VESSELS). ADDITIONALLY, AT THIS TIME, PERI-STENT ANEURYSM WAS NOTED AROUND THE MID AND PROXIMAL RCA STENTS THAT HAD BEEN IMPLANTED IN THE RCA DURING THE INDEX PROCEDURE. IN ADDITION, THE MID RCA STENT WAS NOTED TO BE FRACTURED. THE ANEURYSMS WERE NOT FLOW LIMITING AND THERE WAS NO TREATMENT PLANNED. CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, TOPROL, LIPITOR, IMDUR, AND INTRA-PROCEDURE HEPARIN. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00010, 3003742446-2011-00011 AND 3003742446-2011-00378. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. .
AS REPORTED VIA THE (B)(4) STUDY A PATIENT EXPERIENCED A SIDE BRANCH OCCLUSION OF THE RIGHT POSTERIOR DESCENDING BRANCH (R PDA) AT THE TIME OF THE INDEX PROCEDURE. IT WAS INITIALLY REPORTED THAT THE R PDA WAS TREATED WITH BALLOON ANGIOPLASTY AS PART OF THE INDEX PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 INDICATING THAT PRE-PROCEDURE THE R PDA DIAMETER STENOSIS WAS 15%, AND WAS 60% POST STENTING OF THE DISTAL RCA. AT THE TIME OF THE INDEX PROCEDURE, LESIONS IN THE PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). THE DISTAL RCA LESION WAS 95% STENOSED AND 18MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM BALLOON AT 8ATM AND A 3.5 X 23MM CYPHER RX WAS IMPLANTED AT 11ATM. THE STENT WAS POST-DILATED WITH A 3.0 X 12MM BALLOON AT 8ATM. THE R PDA WAS TREATED WITH BALLOON ANGIOPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | 15092603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |