PALMAZ GENESIS OPTA PRO
Report
- Report Number
- 9616099-2013-00354
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 15, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K012590
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT WAS RETURNED FOR INSPECTION. AS REPORTED, THE BALLOON OF A SHORT PALMAZ GENESIS STENT MOUNTED ON AN OPTA PRO BALLOON CATHETER DID NOT INFLATE DURING TREATMENT OF THE OSTIAL LEFT COMMON CAROTID ARTERY WITH 80% STENOSIS. DURING AN ATTEMPT TO RE-DEPLOY, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT¿S SYMPTOMS WERE REPORTED AS ¿FOGGY AND CONFUSED¿ BUT RESOLVED BY THE END OF THE PROCEDURE AND NO INTERVENTION WAS GIVEN. THERE WERE NO RESIDUAL SYMPTOMS. AN EMBOLIC PROTECTION DEVICE WAS NOT USED. THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. AN ACT WAS NOT REPORTED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO PROBLEMS NOTED DURING PREPARATION. DURING THE PROCEDURE, THE BALLOON WAS PREPPED AND INFLATION WAS ATTEMPTED BUT THE BALLOON WOULD NOT INFLATE. THE ATMOSPHERES OF PRESSURE USED WERE NOT KNOWN. THE STENT DELIVERY SYSTEM WAS RE-PREPPED AND BLOOD WAS NOTED IN THE BALLOON PORT. THE STENT DELIVERY SYSTEM WAS REMOVED WITH THE STENT UNDEPLOYED. ANOTHER PALMAZ GENESIS STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE WITH NO RESIDUAL EFFECTS. ONE NON STERILE CATHETER SHRT GEN / PRO 18 X 70 BIL 135 WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS FOUND IN ITS ORIGINAL PLACE BETWEEN THE MARKER BANDS. NO OTHER DAMAGES WERE NOTED. AN ATTEMPT TO INFLATE THE BALLOON WAS DONE AND DURING INFLATION A BURST WAS FOUND IN THE DISTAL SECTION OF THE BALLOON. SEM RESULTS SHOWED THAT THE BALLOON PRESENTED NO EVIDENCE OF EXTERNAL OR INTERNAL SURFACE DAMAGE. THE DISTAL MARKER BAND EXHIBITED NO ANOMALIES. IT WAS NOT POSSIBLE TO DETERMINE HOW THE OBSERVED CONDITIONS WERE CAUSED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. THE REPORTED ¿INFLATION DIFFICULTY ¿ UNABLE TO¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE; HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED. THE DEVICE WAS NOTED TO HAVE PREPPED PROPERLY (ACCORDING TO INSTRUCTIONS FOR USE). VESSEL CHARACTERISTICS OFTEN CONTRIBUTE TO BALLOON BURST. IN THIS CASE, THE TARGET LESION WAS NOTED TO HAVE 80% STENOSIS. ADDITIONALLY, THE PATIENT REPORTEDLY EXPERIENCED A TRANSIENT ISCHEMIC ATTACK IN WHICH SYMPTOMS RESOLVED BY THE END OF THE PROCEDURE WITHOUT TREATMENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE INABILITY TO INFLATE THE BALLOON OF THE DEVICE WAS CAUSED BY THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.
AS REPORTED, THE BALLOON OF A SHORT PALMAZ GENESIS STENT MOUNTED ON AN OPTA PRO BALLOON CATHETER DID NOT INFLATE DURING TREATMENT OF THE OSTIAL LEFT COMMON CAROTID ARTERY WITH 80% STENOSIS. DURING AN ATTEMPT TO RE-DEPLOY, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT¿S SYMPTOMS WERE REPORTED AS ¿FOGGY AND CONFUSED¿ BUT RESOLVED BY THE END OF THE PROCEDURE AND NO INTERVENTION WAS GIVEN. THERE WERE NO RESIDUAL SYMPTOMS. AN EMBOLIC PROTECTION DEVICE WAS NOT USED. THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. AN ACT WAS NOT REPORTED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO PROBLEMS NOTED DURING PREPARATION. DURING THE PROCEDURE, THE BALLOON WAS PREPPED AND INFLATION WAS ATTEMPTED BUT THE BALLOON WOULD NOT INFLATE. THE ATMOSPHERES OF PRESSURE USED WERE NOT KNOWN. THE STENT DELIVERY SYSTEM WAS RE-PREPPED AND BLOOD WAS NOTED IN THE BALLOON PORT. THE STENT DELIVERY SYSTEM WAS REMOVED WITH THE STENT UNDEPLOYED. ANOTHER PALMAZ GENESIS STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE WITH NO RESIDUAL EFFECTS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITHOUT RETURN OF THE DEVICE THE REPORTED ¿INFLATION DIFFICULTY ¿ UNABLE TO¿ OF THE STENT DELIVERY SYSTEM COULD NOT BE CONFIRMED. BASED ON THE LIMITED INFORMATION AVAILABLE, BLOOD RETURN INTO THE BALLOON PORT MAY HAVE BEEN DUE TO A PINHOLE IN THE DEVICE LEADING TO THE INABILITY TO INFLATE THE BALLOON. PROCEDURAL FACTORS OR VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER AS THE DEVICE PREPPED PROPERLY (ACCORDING TO INSTRUCTIONS FOR USE); HOWEVER, WITHOUT RETURN OF THE DEVICE THE EXACT CAUSE COULD NOT BE DETERMINED. THE PATIENT REPORTEDLY EXPERIENCED A TRANSIENT ISCHEMIC ATTACK BUT WAS NOT TREATED AND SYMPTOMS RESOLVED BY THE END OF THE PROCEDURE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE INABILITY TO INFLATE THE BALLOON OF THE DEVICE WAS CAUSED BY THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.
ADDITIONAL INFORMATION WAS RECEIVED FOR THIS PATIENT. THE ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ADVERSE EVENT OF STROKE AS PREVIOUSLY REPORTED WAS A TRANSIENT ISCHEMIC ATTACK (TIA). THIS EVENT IS BEING CHANGED/CAPTURED AS A NOT REPORTABLE EVENT. THE TARGET LESION WAS AN OSTIAL LEFT COMMON CAROTID ARTERY. THE INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT¿S SYMPTOMS WERE REPORTED TO BE: FOGGY, AND CONFUSED. THE SYMPTOMS WERE REPORTED TO BE RESOLVED BY THE END OF THE PROCEDURE. THE PATIENT EXPERIENCED NO RESIDUAL SYMPTOMS. NO INTERVENTION WAS DONE AS A RESULT. THE LESION WAS REPORTED TO BE: AN 80% STENOSIS. AN EMBOLIC PROTECTION DEVICE WAS NOT USED. DURING THE PROCEDURE, THE BALLOON WAS PREPPED AND THE INFLATION WAS STARTED BUT THE BALLOON WOULD NOT INFLATE. THE STENT BALLOON WAS RE-PREPPED AND BLOOD WAS NOTED IN THE BALLOON PORT. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED WITH THE STENT WHICH WAS NOT DEPLOYED. THE ATMOSPHERES OF PRESSURE USED WERE NOT KNOWN. THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. AN ACT WAS NOT AVAILABLE. ANOTHER PALMAZ GENESIS STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE WITH NO RESIDUAL EFFECTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO PROBLEMS NOTED DURING PREPARATION. THE PRODUCT HAS NOT BEEN RETURNED FOR INSPECTION AS YET. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15444964 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE BALLOON OF THE SHORT PALMAZ GENESIS STENT MOUNTED ON A 135 CM. OPTA PRO 18 X 70 BALLOON CATHETER NEVER EXPANDED. DURING AN ATTEMPT TO RE-DEPLOY, THE PATIENT EXPERIENCED A STROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258237 | PALMAZ GENESIS OPTA PRO | ENDOVASCULAR SDS/STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | 15444964 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L |