PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-05591
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- October 23, 2010
- Report Date
- November 24, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- SIMILAR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). CORRECTED: UPN- SEARCH FROM UNK PROMUS ELEMENT TO H7493911320350; CORRECTED AE OR PRODUCT PROBLEM FROM PRODUCT PROBLEM TO REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM; DESCRIBE EVENT OR PROBLEM, TYPE OF REPORTABLE EVENT CORRECTED FROM PRODUCT PROBLEM TO SERIOUS INJURY; PATIENT CODE. EVENT DATE AND IF IMPLANTED, GIVE DATE: (B)(6) 2011
DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH A TEAR IN THE MIDSHAFT 40MM DISTAL TO THE HYPOTUBE, EXPOSING THE COREWIRE. THE DISTAL SECTION OF THE DEVICE WAS NOT RETURNED. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. 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).
DEVICE IS A 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 BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION TO REPORT, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
SAME CASE AS MFR# 2134265-2011-00312. IT WAS FURTHER REPORTED THAT THE LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. ROTABLATION WAS PERFORMED PRIOR TO STENTING, NOT AFTER STENT AS PREVIOUSLY REPORTED, IN THE MID LAD WITH A 1.5MM BURR. THE BURR GOT STUCK PART WAY THROUGH THE PROCEDURE AND RESULTED IN NO FLOW IN THE LAD. THE PATIENT WAS HAEMODYNAMICALLY UNSTABLE AT THIS POINT. THE LESION WAS REWIRED ALONGSIDE THE BURR USING A NON-BSC WIRE AND A BALLOON WAS DILATED TO DISLODGE THE BURR. THE ROTA WIRE AND ROTA BURR WERE PULLED OUT. NEXT, THE LESION WAS PREDILATED WITH A 2.5 AND A 3.0MM DIAMETER NON-BSC BALLOON. A PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE DISTAL LAD AND THE STENT WAS DEPLOYED AT 12ATMS. THEN A 3.0X38MM PROMUS ELEMENT STENT WAS DEPLOYED AT 14 ATMS WITHOUT DIFFICULTY. IMMEDIATELY AFTER STENT DEPLOYMENT, THE STENT WAS FULLY EXPANDED. THE LESION IN THE CIRCUMFLEX (CX) WAS PREDILATED WITH A 3MM NON-BSC BALLOON. AN ANCHOR BALLOON TECHNIQUE WAS USED TO PROVIDE ADDITIONAL SUPPORT WHILE ADVANCING A 3.5X20MM PROMUS ELEMENT SDS TO THE CIRCUMFLEX. THE STENT WAS DEPLOYED AT 14 ATMS IN THE TARGET LESION. IT WAS REPORTED THAT THE 3.5X20MM PROMUS ELEMENT SDS SHAFT BROKE AT THE MID HYPOTUBE. ATTEMPTS WERE MADE TO REMOVE THE BROKEN SHAFT WITH A 2.5MM SEMI COMPLIANT BALLOON AND A SNARE BUT BOTH WERE UNSUCCESSFUL. AN ADDITIONAL 3.0X16MM PROMUS ELEMENT STENT DEPLOYED AT 16ATMS WAS USED TO CRUSH THE DEVICE AGAINST A VESSEL WALL AND THE STENT. NO ADDITIONAL DEVICE COULD BE ADVANCED TO THE CX. DURING WITHDRAWAL OF THE ANCHOR BALLOON FROM THE CX, IT WAS NOTED THAT THERE WAS AN AXIAL LENGTH CHANGE ON THE 3.0X38MM PROMUS ELEMENT STENT. AN ADDITIONAL 4X38MM PROMUS ELEMENT STENT WAS DEPLOYED AT 16ATMS TO SECURE AND APPOSE THE 3.0X38MM PROMUS ELEMENT STENT AGAINST THE VESSEL WALL. THE LESION WAS POST DILATED WITH A 3.75X15MM NON-COMPLIANT BALLOON. THE PATIENT HAD TIMI III FLOW IN THE LAD. THE CX VESSEL HAD TIMI II FLOW. THE PATIENT WAS INTUBATED / VENTILATED AND PUT ON A BALLOON PUMP THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT STATUS IS STABLE.
SAME CASE AS MFR# 2134265-2011-00312. IT WAS FURTHER REPORTED THAT THE LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. ROTABLATION WAS PERFORMED PRIOR TO STENTING, NOT AFTER STENT AS PREVIOUSLY REPORTED, IN THE MID LAD WITH A 1.5MM BURR. THE BURR GOT STUCK PART WAY THROUGH THE PROCEDURE AND RESULTED IN NO FLOW IN THE LAD. THE PATIENT WAS HAEMODYNAMICALLY UNSTABLE AT THIS POINT. THE LESION WAS REWIRED ALONGSIDE THE BURR USING A NON-BSC WIRE AND A BALLOON WAS DILATED TO DISLODGE THE BURR. THE ROTA WIRE AND ROTA BURR WERE PULLED OUT. NEXT, THE LESION WAS PREDILATED WITH A 2.5 AND A 3.0MM DIAMETER NON-BSC BALLOON. A PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE DISTAL LAD AND THE STENT WAS DEPLOYED AT 12ATMS. THEN A 3.0X38MM PROMUS ELEMENT STENT WAS DEPLOYED AT 14 ATMS WITHOUT DIFFICULTY. IMMEDIATELY AFTER STENT DEPLOYMENT, THE STENT WAS FULLY EXPANDED. THE LESION IN THE CIRCUMFLEX (CX) WAS PREDILATED WITH A 3MM NON-BSC BALLOON. AN ANCHOR BALLOON TECHNIQUE WAS USED TO PROVIDE ADDITIONAL SUPPORT WHILE ADVANCING A 3.5X20MM PROMUS ELEMENT SDS TO THE CIRCUMFLEX. THE STENT WAS DEPLOYED AT 14 ATMS IN THE TARGET LESION. IT WAS REPORTED THAT THE 3.5X20MM PROMUS ELEMENT SDS SHAFT BROKE AT THE MID HYPOTUBE. ATTEMPTS WERE MADE TO REMOVE THE BROKEN SHAFT WITH A 2.5MM SEMI COMPLIANT BALLOON AND A SNARE BUT BOTH WERE UNSUCCESSFUL. AN ADDITIONAL 3.0X16MM PROMUS ELEMENT STENT DEPLOYED AT 16ATMS WAS USED TO CRUSH THE DEVICE AGAINST A VESSEL WALL AND THE STENT. NO ADDITIONAL DEVICE COULD BE ADVANCED TO THE CX. DURING WITHDRAWAL OF THE ANCHOR BALLOON FROM THE CX, IT WAS NOTED THAT THERE WAS AN AXIAL LENGTH CHANGE ON THE 3.0X38MM PROMUS ELEMENT STENT. AN ADDITIONAL 4X38MM PROMUS ELEMENT STENT WAS DEPLOYED AT 16ATMS TO SECURE AND APPOSE THE 3.0X38MM PROMUS ELEMENT STENT AGAINST THE VESSEL WALL. THE LESION WAS POST DILATED WITH A 3.75X15MM NON-COMPLIANT BALLOON. THE PATIENT HAD TIMI III FLOW IN THE LAD. THE CX VESSEL HAD TIMI II FLOW. THE PATIENT WAS INTUBATED / VENTILATED AND PUT ON A BALLOON PUMP THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT STATUS IS STABLE.
SAME CASE AS MFR# 2134265-2010-05530 AND 2134265-2010-05592. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE THREE TARGET LESIONS WERE LOCATED IN THREE UNSPECIFIED VESSELS. A PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS USED TO TREAT ONE LESION, HOWEVER THE STENT "CONCERTINARED" IN THE VESSEL. ANOTHER PROMUS ELEMENT SDS WAS USED IN THE SECOND VESSEL. AFTER DEPLOYING THE STENT, THE BALLOON GOT STUCK. LASTLY, A ROTABLATOR WAS USED IN THE THIRD VESSEL. DURING ROTABLATION, THE BURR GOT STUCK IN THE VESSEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493911320350 | 13667860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |