PROMUS PREMIER?
Report
- Report Number
- 2134265-2014-03318
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 20, 2014
- Report Date
- May 20, 2014
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P110010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MFR: THE BALLOON CONES PROFILES AND THE BALLOON TUBE PROFILE WERE REVIEWED. INITIAL ANALYSIS OF THE BALLOON NOTED THE BALLOON WAS FULLY DEFLATED WITH THE BALLOON WINGS TIGHTLY WRAPPED AND EVENLY FOLDED. AS PART OF THE EXAMINATION THE BALLOON WAS INFLATED. NO ISSUES WERE OBSERVED WITH THE BALLOON WALL OR THE INNER LUMEN DURING OR AFTER INFLATION. THERE WERE ALSO NO DIFFICULTIES WITH BALLOON DEFLATION. THE STENT WAS NOT RETURNED FOR ANALYSIS AS IT WAS PLACED IN THE MIDDLE OF THE LESION; HOWEVER CRIMP MARKINGS WERE EVIDENT ON THE WALL OF THE BALLOON AS WOULD BE EXPECTED. A MICROSCOPIC EXAMINATION OF THE BI-COMPONENT BOND LOCATION, MIDSHAFT BOND, PORT BOND, INNER LUMEN AND OUTER FOUND NO EVIDENCE OF DEFECTS OR DAMAGE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT.
IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED USING A 1.2X15MM AND A 2.0X15MM NON BSC BALLOON CATHETERS. THEN THE 20MM X 2.25MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS. THE DEVICE REACHED THE MIDDLE OF THE LESION BUT THE PHYSICIAN HAD DIFFICULTY IN RETRACTING THE DEVICE. THERE WAS A CONCERN THAT THE SHAFT WOULD BE DETACHED SO THE PHYSICIAN DEPLOYED THIS DEVICE IN THE MID LAD. THE DISTAL LAD WAS DILATED WITH A 2.0MM UNSPECIFIED BALLOON CATHETER. A 2.25MM X 12M PROMUS PREMIER¿ STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE NOTED AND PATIENT'S STATUS IS GOOD.
IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED USING A 1.2X15MM AND A 2.0X15MM NON BSC BALLOON CATHETERS. THEN THE 20MM X 2.25MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS. THE DEVICE REACHED THE MIDDLE OF THE LESION BUT THE PHYSICIAN HAD DIFFICULTY IN RETRACTING THE DEVICE. THERE WAS A CONCERN THAT THE SHAFT WOULD BE DETACHED SO THE PHYSICIAN DEPLOYED THIS DEVICE IN THE MID LAD. THE DISTAL LAD WAS DILATED WITH A 2.0MM UNSPECIFIED BALLOON CATHETER. A 2.25MM X 12M PROMUS PREMIER¿ STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE NOTED AND PATIENT'S STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357641 | PROMUS PREMIER? | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493925120220 | 16737366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | GUIDE WIRE: SION BLUE (ASAHI INTECC)| BALLOON CATHETER: SAPPHIRE 1.2 X 15 MM (OBUSNEICH)| INTRODUCER SHEATH: (TERUMO)| INFLATION DEVICE: (ST.JUDE MEDICAL)| BALLOON CATHETER:SCOREFLEX 2.0X15MM (ORBUSNEICH)| GUIDING CATHETER: PROFIT 6FJL3.5 (GOODMAN) |