PROMUS PREMIER SELECT
Report
- Report Number
- 2124215-2023-60217
- Event Type
- Injury
- Date Received
- November 7, 2023
- Date of Event
- October 16, 2023
- Report Date
- April 1, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Removal / Correction Number
- 97172244-FA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6: IMPACT CODE: REPLACED WITH F2301. H6: DEVICE CODE: UPDATED TO ADD A150101.
B2: SELECTION REMOVED. B5: ADDITIONAL DETAILS ADDED. H6: IMPACT CODE: REPLACED WITH F26: NO HEALTH CONSEQUENCES OR IMPACT. DEVICE HISTORY RECORD REVIEW: A DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED FOR THE PROMUS PREMIER SELECT REFERENCED BATCH (0031891839). THE MANUFACTURING REVIEW CONFIRMED THAT ALL DEVICES ASSOCIATED WITH THIS BATCH WERE THE CORRECT SIZE (16 MM X 2.75 MM) PER MANUFACTURING RECORDS AND BOX LABELLING. THE PROMUS PREMIER SELECT 16 MM X 2.75 MM HAS A MINIMUM STENT LENGTH SPECIFICATION OF 15.71 MM, AND A MAXIMUM STENT LENGTH SPECIFICATION OF 17.21 MM. ANY STENT LENGTH THAT FALLS OUTSIDE OF THESE LIMITS IS AUTOMATICALLY SCRAPPED. ALL DISTRIBUTED DEVICES FROM FINISHED GOODS BATCH (FGB) 0031891839 PASSED THIS INSPECTION AND WERE WITHIN THE SPECIFIED STENT LENGTH LIMITS. FROM THE THOROUGH INVESTIGATION OF ALL DATA GATHERED, IT IS NOT POSSIBLE FOR A FGB OF 16 MM X 2.75 MM DEVICES TO INCLUDE A 20 MM X 4.00 MM SIZED DEVICE. ALTHOUGH THE CURRENT MANUFACTURING CONTROLS CONFIRMED THAT ALL DEVICES IN BATCH 0031891839 WERE CORRECTLY MEASURED AS 16 MM X 2.75 MM STENTS, THE MISPRINT ON THE ACTUAL HUB WAS NOT IDENTIFIED DURING MANUFACTURING. MEDIA REVIEW AND ANALYSIS: PROCEDURAL MEDIA WAS PROVIDED TO BSC FOR REVIEW. MEDIA REVIEW BY A BSC MEDICAL SAFETY DIRECTOR OBSERVED A LESION PRESENT IMMEDIATELY NEAR A PREVIOUSLY IMPLANTED STENT IN THE MID-LAD. PRE-DILATATION WAS PERFORMED, AND A STENT WAS ADVANCED AND POSITIONED WITH MINIMAL OVERLAP WITH THE PREVIOUS STENT. THIS STENT WAS IMPLANTED SUCCESSFULLY AND POST-DILATATION WAS PERFORMED. THE STENT APPEARED TO BE EXPANDED AND WITHIN THE PROPER SIZE COMPARED TO THE VESSEL WALL. APPOSITION OR OTHER ASSUMPTIONS CANNOT BE MADE BASED ON THE MEDIA PROVIDED. IT WAS FURTHER OBSERVED THAT TREATMENT WITH ANOTHER STENT (LARGER IN DIAMETER) IN A DIFFERENT LESION OF THE PROXIMAL LAD (PROXIMAL TO THE PREVIOUSLY IMPLANTED STENTS). THE REFERENCED DEVICE WAS NOT RETURNED FOR LABORATORY ANALYSIS; HOWEVER, AN INVESTIGATION WAS PERFORMED WITH ALL AVAILABLE INFORMATION. IT WAS REPORTED THAT THE STENT LOOKED RADIOLOGICALLY BIGGER THAN EXPECTED, BALLOON INFLATION WAS STOPPED AT 6 ATMOSPHERES, AND NO POST DILATATION WAS PERFORMED. HOWEVER, BSC MEDICAL SAFETY MEDIA REVIEW NOTED THAT POST-DILATATION WAS PERFORMED IN THIS CASE. NOMINAL INFLATION PRESSURE FOR THE 2.75 MM PROMUS PREMIER SELECT STENT IS 11 ATMOSPHERES, WITH A RATED BURST PRESSURE OF 18 ATMOSPHERES. SINCE THE BALLOON WAS REPORTEDLY NOT INFLATED TO ITS NOMINAL PRESSURE, THIS LIKELY RESULTED IN A PARTIAL STENT DEPLOYMENT AND RESULTED IN THE REPORTED POOR INADEQUATE STENT APPOSITION. A SIMILAR EVENT (BSC REFERENCE (B)(4): FDA REFERENCE 2124215-2023-74711) FROM THE SAME PROMUS PREMIER SELECT CORONARY STENT SYSTEM BATCH (0031891839) WAS REPORTED TO BSC ON A LATER DATE. IN THIS CASE, THE DEVICE WAS RETURNED FOR LABORATORY ANALYSIS. DEVICE ANALYSIS PERFORMED CONFIRMED THAT THERE WAS A MISPRINT ON THE HUB MANIFOLD. WHILE THE ACTUAL DEVICE MEASURED CORRECTLY PER THE BOX LABELLING, WHICH WAS LABELLED AS A 16 MM X 2.75 MM PROMUS PREMIER SELECT CORONARY STENT SYSTEM, THE SIZE PRINTED ON THE HUB INDICATED 4.00 MM X 20 MM. A NON-CONFIRMING EVENTS PREVENTION (NCEP) INVESTIGATION HAS BEEN INITIATED TO IDENTIFY THE CAUSE OF THE CONFIRMED MANUFACTURING DEFICIENCY ASSOCIATED WITH THE INCORRECT PRODUCT SIZE ETCHED ON THE HUB MANIFOLDS FROM THIS BATCH 0031891839. LABELING REVIEW: BASED ON THE AVAILABLE INFORMATION, THERE WAS NO EVIDENCE OF DEVICE MISUSE, OFF-LABEL USE, OR FAILURE TO FOLLOW THE PROMUS PREMIER SELECT CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). UPON MEDICAL SAFETY REVIEW, IT APPEARS THE DEVICE WAS USED APPROPRIATELY AND AS INTENDED IN ACCORDANCE WITH THE IFU. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED EVENT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF 'MANUFACTURING DEFICIENCY', SINCE THE PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. ALTHOUGH THE REFERENCED PROMUS PREMIER SELECT DEVICE ((B)(4)) WAS NOT RECEIVED FOR ANALYSIS, REVIEW OF A SIMILAR EVENT ((B)(4)) REPORTED WITH RETURNED DEVICE ANALYSIS FOR THIS SPECIFIC DEVICE BATCH (0031891839) FOUND THAT ALTHOUGH THE DEVICES IN THIS BATCH MEASURE CORRECTLY PER CURRENT MANUFACTURING CONTROLS, THE HUB MANIFOLD WAS INCORRECTLY ETCHED WITH A PRODUCT SIZE OF 20 MM X 4.0 MM. MM. THIS MAY HAVE CONTRIBUTED TO THE REPORTED POOR/INADEQUATE STENT APPOSITION. A NON-CONFORMING EVENTS PREVENTION (NCEP) INVESTIGATION HAS BEEN INITIATED TO IDENTIFY THE CAUSE OF THE CONFIRMED MANUFACTURING DEFICIENCY ASSOCIATED WITH THE INCORRECT PRODUCT SIZE ETCHED ON THE HUB MANIFOLDS FROM THIS BATCH (0031891839).
H7 IF REMEDIAL ACT OTHER, SPECIFY: UPDATED H9 CORRECTION/REMOVAL REPORTING #: UPDATED AN NCEP INVESTIGATION HAS BEEN INITIATED TO IDENTIFY THE CAUSE OF THE INCORRECT PRODUCT SIZE ETCHED ON THE HUB MANIFOLDS FROM THIS BATCH (0031891839). IN ADDITION, BOSTON SCIENTIFIC INITIATED A MEDICAL DEVICE REMOVAL (97172244-FA) OF BATCH 0031891839 OF PROMUS PREMIER SELECT CORONARY STENT SYSTEMS ON 11 MARCH 2024 DUE TO AN INCORRECT PRODUCT SIZE PRINTED ON THE CATHETER MANIFOLD HUB. B2: SELECTION REMOVED. B5: ADDITIONAL DETAILS ADDED. H6: IMPACT CODE: REPLACED WITH F26: NO HEALTH CONSEQUENCES OR IMPACT. DEVICE HISTORY RECORD REVIEW: A DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED FOR THE PROMUS PREMIER SELECT REFERENCED BATCH (0031891839). THE MANUFACTURING REVIEW CONFIRMED THAT ALL DEVICES ASSOCIATED WITH THIS BATCH WERE THE CORRECT SIZE (16 MM X 2.75 MM) PER MANUFACTURING RECORDS AND BOX LABELLING. THE PROMUS PREMIER SELECT 16 MM X 2.75 MM HAS A MINIMUM STENT LENGTH SPECIFICATION OF 15.71 MM, AND A MAXIMUM STENT LENGTH SPECIFICATION OF 17.21 MM. ANY STENT LENGTH THAT FALLS OUTSIDE OF THESE LIMITS IS AUTOMATICALLY SCRAPPED. ALL DISTRIBUTED DEVICES FROM FINISHED GOODS BATCH (FGB) 0031891839 PASSED THIS INSPECTION AND WERE WITHIN THE SPECIFIED STENT LENGTH LIMITS. FROM THE THOROUGH INVESTIGATION OF ALL DATA GATHERED, IT IS NOT POSSIBLE FOR A FGB OF 16 MM X 2.75 MM DEVICES TO INCLUDE A 20 MM X 4.00 MM SIZED DEVICE. ALTHOUGH THE CURRENT MANUFACTURING CONTROLS CONFIRMED THAT ALL DEVICES IN BATCH 0031891839 WERE CORRECTLY MEASURED AS 16 MM X 2.75 MM STENTS, THE MISPRINT ON THE ACTUAL HUB WAS NOT IDENTIFIED DURING MANUFACTURING. MEDIA REVIEW AND ANALYSIS: PROCEDURAL MEDIA WAS PROVIDED TO BSC FOR REVIEW. MEDIA REVIEW BY A BSC MEDICAL SAFETY DIRECTOR OBSERVED A LESION PRESENT IMMEDIATELY NEAR A PREVIOUSLY IMPLANTED STENT IN THE MID-LAD. PRE-DILATATION WAS PERFORMED, AND A STENT WAS ADVANCED AND POSITIONED WITH MINIMAL OVERLAP WITH THE PREVIOUS STENT. THIS STENT WAS IMPLANTED SUCCESSFULLY AND POST-DILATATION WAS PERFORMED. THE STENT APPEARED TO BE EXPANDED AND WITHIN THE PROPER SIZE COMPARED TO THE VESSEL WALL. APPOSITION OR OTHER ASSUMPTIONS CANNOT BE MADE BASED ON THE MEDIA PROVIDED. IT WAS FURTHER OBSERVED THAT TREATMENT WITH ANOTHER STENT (LARGER IN DIAMETER) IN A DIFFERENT LESION OF THE PROXIMAL LAD (PROXIMAL TO THE PREVIOUSLY IMPLANTED STENTS). THE REFERENCED DEVICE WAS NOT RETURNED FOR LABORATORY ANALYSIS; HOWEVER, AN INVESTIGATION WAS PERFORMED WITH ALL AVAILABLE INFORMATION. IT WAS REPORTED THAT THE STENT LOOKED RADIOLOGICALLY BIGGER THAN EXPECTED, BALLOON INFLATION WAS STOPPED AT 6 ATMOSPHERES, AND NO POST DILATATION WAS PERFORMED. HOWEVER, BSC MEDICAL SAFETY MEDIA REVIEW NOTED THAT POST-DILATATION WAS PERFORMED IN THIS CASE. NOMINAL INFLATION PRESSURE FOR THE 2.75 MM PROMUS PREMIER SELECT STENT IS 11 ATMOSPHERES, WITH A RATED BURST PRESSURE OF 18 ATMOSPHERES. SINCE THE BALLOON WAS REPORTEDLY NOT INFLATED TO ITS NOMINAL PRESSURE, THIS LIKELY RESULTED IN A PARTIAL STENT DEPLOYMENT AND RESULTED IN THE REPORTED POOR INADEQUATE STENT APPOSITION. A SIMILAR EVENT (BSC REFERENCE 17570841: FDA REFERENCE 2124215-2023-74711) FROM THE SAME PROMUS PREMIER SELECT CORONARY STENT SYSTEM BATCH (0031891839) WAS REPORTED TO BSC ON A LATER DATE. IN THIS CASE, THE DEVICE WAS RETURNED FOR LABORATORY ANALYSIS. DEVICE ANALYSIS PERFORMED CONFIRMED THAT THERE WAS A MISPRINT ON THE HUB MANIFOLD. WHILE THE ACTUAL DEVICE MEASURED CORRECTLY PER THE BOX LABELLING, WHICH WAS LABELLED AS A 16 MM X 2.75 MM PROMUS PREMIER SELECT CORONARY STENT SYSTEM, THE SIZE PRINTED ON THE HUB INDICATED 4.00 MM X 20 MM. A NON-CONFIRMING EVENTS PREVENTION (NCEP) INVESTIGATION HAS BEEN INITIATED TO IDENTIFY THE CAUSE OF THE CONFIRMED MANUFACTURING DEFICIENCY ASSOCIATED WITH THE INCORRECT PRODUCT SIZE ETCHED ON THE HUB MANIFOLDS FROM THIS BATCH 0031891839. LABELING REVIEW: BASED ON THE AVAILABLE INFORMATION, THERE WAS NO EVIDENCE OF DEVICE MISUSE, OFF-LABEL USE, OR FAILURE TO FOLLOW THE PROMUS PREMIER SELECT CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). UPON MEDICAL SAFETY REVIEW, IT APPEARS THE DEVICE WAS USED APPROPRIATELY AND AS INTENDED IN ACCORDANCE WITH THE IFU. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED EVENT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF 'MANUFACTURING DEFICIENCY', SINCE THE PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. ALTHOUGH THE REFERENCED PROMUS PREMIER SELECT DEVICE (17323868) WAS NOT RECEIVED FOR ANALYSIS, REVIEW OF A SIMILAR EVENT (17570841) REPORTED WITH RETURNED DEVICE ANALYSIS FOR THIS SPECIFIC DEVICE BATCH (0031891839) FOUND THAT ALTHOUGH THE DEVICES IN THIS BATCH MEASURE CORRECTLY PER CURRENT MANUFACTURING CONTROLS, THE HUB MANIFOLD WAS INCORRECTLY ETCHED WITH A PRODUCT SIZE OF 20 MM X 4.0 MM. MM. THIS MAY HAVE CONTRIBUTED TO THE REPORTED POOR/INADEQUATE STENT APPOSITION. A NON-CONFORMING EVENTS PREVENTION (NCEP) INVESTIGATION HAS BEEN INITIATED TO IDENTIFY THE CAUSE OF THE CONFIRMED MANUFACTURING DEFICIENCY ASSOCIATED WITH THE INCORRECT PRODUCT SIZE ETCHED ON THE HUB MANIFOLDS FROM THIS BATCH (0031891839).
IT WAS REPORTED THAT A STENT LABELING ISSUE OCCURRED. A 16MM X 2.75 PROMUS PREMIER SELECT WAS SELECTED FOR USE TO TREAT A TARGET LESION LOCATED IN MID LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PROCEDURE, THE STENT WAS PREPARED ACCORDING TO THE SIZE IMPRINT ON THE CARDBOARD BOX AND OUTER PACKAGING. FOLLOWING BALLOON INFLATION, IT WAS NOTICED THAT THE STENT WAS BIGGER (4.0 X 20 MM) THAN THE EXPECTED SIZE AND WAS UNDER EXPANDED. THE PREPARED STENT (4.0 X 20 MM) WAS IMPLANTED AND AN ADDITIONAL STENT WITH THE INTENDED DIMENSIONS WAS PLACED IN THE LESION TO AVOID RECOIL. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) THAT THE REFERENCED 16 MM X 2.75 MM PROMUS PREMIER SELECT CORONARY STENT SYSTEM WAS SELECTED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY IN A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS PREPARED ACCORDING TO THE SIZE IMPRINT ON THE CARDBOARD BOX AND OUTER PACKAGING. FOLLOWING BALLOON INFLATION, IT WAS NOTICED THAT THE STENT WAS BIGGER (I.E., 20 MM X 4.0 MM) THAN THE EXPECTED SIZE AND WAS UNDER EXPANDED. THE REFERENCED STENT REMAINED IMPLANTED IN THE TARGET VESSEL AND AN ADDITIONAL STENT (16 MM X 2.75 MM) WAS IMPLANTED IN THE LESION TO AVOID RECOIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT, SINCE THE STENT LOOKED RADIOLOGICALLY BIGGER THAN EXPECTED (VISUALLY CONTROLLED ON THE BALLOON SHAFT IT WAS A 4.0MM STENT INSTEAD OF 2.75MM) BALLOON INFLATION WAS STOPPED AT 6 ATM AND KEPT FOR 30 SECONDS INFLATED. THEREAFTER NO POST DILATION OR OTHER MEASUREMENTS WERE TAKEN. NO DISSECTION OR ANY LEAKAGE WAS OBSERVED. THERE WAS NO ADDITIONAL STENT IMPLANTED. PROCEDURE WAS COMPLETED WITHOUT ANY ACUTE COMPLICATION. PATIENT WAS DISCHARGED EVENT-FREE.
IT WAS REPORTED THAT A STENT LABELING ISSUE OCCURRED. A 16MM X 2.75 PROMUS PREMIER SELECT WAS SELECTED FOR USE TO TREAT A TARGET LESION LOCATED IN MID LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PROCEDURE, THE STENT WAS PREPARED ACCORDING TO THE SIZE IMPRINT ON THE CARDBOARD BOX AND OUTER PACKAGING. FOLLOWING BALLOON INFLATION, IT WAS NOTICED THAT THE STENT WAS BIGGER (4.0 X 20 MM) THAN THE EXPECTED SIZE AND WAS UNDER EXPANDED. THE PREPARED STENT (4.0 X 20 MM) WAS IMPLANTED AND AN ADDITIONAL STENT WITH THE INTENDED DIMENSIONS WAS PLACED IN THE LESION TO AVOID RECOIL. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) THAT THE REFERENCED 16 MM X 2.75 MM PROMUS PREMIER SELECT CORONARY STENT SYSTEM WAS SELECTED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY IN A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS PREPARED ACCORDING TO THE SIZE IMPRINT ON THE CARDBOARD BOX AND OUTER PACKAGING. FOLLOWING BALLOON INFLATION, IT WAS NOTICED THAT THE STENT WAS BIGGER (I.E., 20 MM X 4.0 MM) THAN THE EXPECTED SIZE AND WAS UNDER EXPANDED. THE REFERENCED STENT REMAINED IMPLANTED IN THE TARGET VESSEL AND AN ADDITIONAL STENT (16 MM X 2.75 MM) WAS IMPLANTED IN THE LESION TO AVOID RECOIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2024 YK: IT WAS FURTHER REPORTED THAT, SINCE THE STENT LOOKED RADIOLOGICALLY BIGGER THAN EXPECTED (VISUALLY CONTROLLED ON THE BALLOON SHAFT IT WAS A 4.0MM STENT INSTEAD OF 2.75MM) BALLOON INFLATION WAS STOPPED AT 6 ATM AND KEPT FOR 30 SECONDS INFLATED. THEREAFTER NO POST DILATION OR OTHER MEASUREMENTS WERE TAKEN. NO DISSECTION OR ANY LEAKAGE WAS OBSERVED. THERE WAS NO ADDITIONAL STENT IMPLANTED. PROCEDURE WAS COMPLETED WITHOUT ANY ACUTE COMPLICATION. PATIENT WAS DISCHARGED EVENT-FREE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350245 | PROMUS PREMIER SELECT | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC CORPORATION | 10663 | 0031891839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |