ION?
Report
- Report Number
- 2134265-2013-00849
- Event Type
- Injury
- Date Received
- February 14, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 17, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- NIQ
- PMA / PMN Number
- P100023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
CORRECTION: DESCRIBE EVENT OR PROBLEM. RESPONSE TO FDA REQUEST. (B)(4).
UPDATE: DESCRIBE EVENT OR PROBLEM. CORRECTION: DESCRIBE EVENT OR PROBLEM. (B)(4).
(B)(4).
PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).
SAME PATIENT AS MDR ID# 2134265-2013-02024. SAME CASE AS MDR ID# 2134265-2013-00850. IT WAS FURTHER REPORTED DURING THE PROCEDURE THAT TOOK PLACE IN (B)(6) 2011, THE PHYSICIAN ATTEMPTED TO ADVANCE A LUGE GUIDEWIRE INTO THE RAMUS BUT WAS NOT ABLE TO CROSS THE LESION. THE PHYSICIAN THEN ATTEMPTED TO CROSS THE RAMUS WITH A PT GRAPHIX GUIDEWIRE BUT STILL COULD NOT CROSS THE LESION. POST IMPLANT OF THE 3.00 X 20 MM ION US COA STENT IN THE DISTAL LEFT MAIN CORONARY ARTERY (LMCA) TO PROXIMAL LCX, THERE WAS A JAILING OF THE LAD. THIS WAS TREATED WITH THE WIRING AND DILATATION USING A 2.75 X 15 MM NON BSC BALLOON THROUGH THE STENT STRUTS WHICH WERE "CROSSING THE LAD". IT WAS ALSO FURTHER REPORTED IN (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST DISCOMFORT ASSOCIATED WITH SHORTNESS OF BREATH WITH RADIATION TO THE UPPER EXTREMITIES AND WAS DIAPHORETIC; 90% STENT THROMBOSIS WAS ORIGINALLY REPORTED FOR THE PREVIOUSLY PLACED STENTS IN THE LEFT MAIN CORONARY ARTERY EXTENDING TO THE PROXIMAL LEFT CIRCUMFLEX AND HAS BEEN CORRECTED TO 95% IN-STENT RESTENOSIS OF THE STUDY STENTS.
A CORRECTION TO THE ORIGINALLY REPORTED INFORMATION HAS BEEN MADE: TARGET LESION TWO WAS ORIGINALLY REPORTED AS BEING LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) EXTENDING IN TO PROXIMAL LCX. THE CORRECTION RECEIVED IS THAT TARGET LESION TWO WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) TO DISTAL LCX.
IT WAS FURTHER REPORTED THAT THE INITIALLY REPORTED LOCATION FOR TARGET VESSEL TWO WAS CORRECT. TARGET LESION #2 WAS LOCATED IN THE ¿LMCA TO PROXIMAL LCX¿ WHICH HAS BEEN CHANGED FROM ¿PROXIMAL LCX TO DISTAL LCX¿.
(B)(4) STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION, THROMBOSIS, AND ISCHEMIC SYMPTOMS. INDEX PROCEDURE. (B)(6) 2011 - THE PATIENT PRESENTED DUE TO SILENT ISCHEMIA. THE 80%STENOSED TARGET LESION WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. USING A DIRECT STENTING METHOD THE PHYSICIAN PLACED A 2.75 X 16MM ION STENT. FOLLOWING POST DILATATION WITH AN UNKNOWN BALLOON CATHETER, RESIDUAL STENOSIS WAS 0%. THE PHYSICIAN ALSO TREATED THE 70% STENOSED, DE NOVO TARGET LESION, 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM, LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX), WITH DIRECT STENT PLACEMENT OF A 3.00 MM X 20 MM ION US COA STENT, WITH 0% RESIDUAL STENOSIS. (B)(6) 2013 - THE PATIENT PRESENTED WITH A NON Q-WAVE MYOCARDIAL INFARCTION, ISCHEMIC SYMPTOMS AND WAS HOSPITALIZED ON THE SAME DAY. THE 90% FOCAL RESTENOSIS OF THE PREVIOUSLY PLACED 3.00 MM X 20 MM ION STENT LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) EXTENDING IN TO PROXIMAL LCX. ADDITIONALLY THERE WAS A STENT THROMBOSIS NOTED IN THE PREVIOUSLY PLACED STENTS IN THE LMCA TO PROXIMAL LCX. THIS WAS TREATED WITH BALLOON ANGIOPLASTY AND THE PLACEMENT OF 3.0 MM X 15 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. THE 70% DIFFUSE RESTENOSIS OF THE PREVIOUSLY PLACED 2.75 MM X 16 MM ION LOCATED IN THE PROXIMAL LAD WAS TREATED WITH A LUGE WIRE BUT COULD NOT CROSS THE LESION. A PT GRAPHIX GUIDE WIRE WAS USED TO ATTEMPT TO WIRE THROUGH THE STENT STRUTS BUT IT WAS UNSUCCESSFUL AS WELL. THE PHYSICIAN COMPLETED TREATMENT WITH BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. TWO DAYS LATER THE EVENTS WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65670 | ION? | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - MAPLE GROVE | H7493902416270 | 14766207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R |