MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING

Model Number 10665

Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified ight anterior interventricular artery.Pre-dilation was performed with a 2.50mm x 20mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190cm samurai guidewire, resistance was felt again and then a thread approximately 15cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified ight anterior interventricular artery.Pre-dilation was performed with a 2.50mm x 20mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190cm samurai guidewire, resistance was felt again and then a thread approximately 15cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.The promus premier select stent delivery system was returned for analysis with a piece of foreign material (fm) wrapped in cloth returned separate to the device.The stent was not returned for analysis as it was implanted in the patient.A visual and microscopic examination of the bumper tip showed signs of damage.The balloon cones were reviewed and no issues were noted.The balloon folds appear relaxed from their original folded position and it appears that positive pressure was applied and a vacuum pulled.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.A visual and tactile examination of the shaft polymer extrusion found no issues along the midshaft, inner or outer shaft polymer extrusion.The fm was returned separate to the device wrapped in a piece of cloth.The fm measured 245 mm in length.The fm was analyzed using fourier transform infra-red spectroscopy.The spectrum produced would suggest that the fm is polytetrafluoroethylene (ptfe).

Manufacturer Narrative

Device is a combination product.

Manufacturer Narrative

Device is a combination product.Root cause was changed from 67 no problem detected to 4311 adverse event related to procedure.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 01/15/2019 08:45 am ct.The report number is being corrected from: 2134265-2018-64265to: 2134265-2018-61515.

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified ight anterior interventricular artery.Pre-dilation was performed with a 2.50mm x 20mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190cm samurai guidewire, resistance was felt again and then a thread approximately 15cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.The promus premier select stent delivery system was returned for analysis with a piece of foreign material (fm) wrapped in cloth returned separate to the device.The stent was not returned for analysis as it was implanted in the patient.A visual and microscopic examination of the bumper tip showed signs of damage.The balloon cones were reviewed and no issues were noted.The balloon folds appear relaxed from their original folded position and it appears that positive pressure was applied and a vacuum pulled.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.A visual and tactile examination of the shaft polymer extrusion found no issues along the midshaft, inner or outer shaft polymer extrusion.The fm was returned separate to the device wrapped in a piece of cloth.The fm measured 245 mm in length.The fm was analyzed using fourier transform infra-red spectroscopy.The spectrum produced would suggest that the fm is polytetrafluoroethylene (ptfe).

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified right anterior interventricular artery.Pre-dilation was performed with a 2.50mm x 20mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190cm samurai guidewire, resistance was felt again and then a thread approximately 15cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.The promus premier select stent delivery system was returned for analysis with a piece of foreign material (fm) wrapped in cloth returned separate to the device.The stent was not returned for analysis as it was implanted in the patient.A visual and microscopic examination of the bumper tip showed signs of damage.The balloon cones were reviewed and no issues were noted.The balloon folds appear relaxed from their original folded position and it appears that positive pressure was applied and a vacuum pulled.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.A visual and tactile examination of the shaft polymer extrusion found no issues along the midshaft, inner or outer shaft polymer extrusion.The fm was returned separate to the device wrapped in a piece of cloth.The fm measured 245 mm in length.The fm was analyzed using fourier transform infra-red spectroscopy.The spectrum produced would suggest that the fm is polytetrafluoroethylene (ptfe).

Manufacturer Narrative

Device is a combination product.Root cause was changed from cause not established to no problem detected.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 12:45 pm ct.The report number is being corrected from: 2134265-2018-64265 to: 2134265-2018-61515.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7956372
• MDR Text Key: 123405134
• Report Number: 2134265-2018-61515
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2020
• Device Model Number: 10665
• Device Catalogue Number: 10665
• Device Lot Number: 0022094008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT VISTA BRIGHT GUIDE CATHETER; ABBOTT VISTA BRIGHT GUIDE CATHETER; ABBOTT VISTA BRIGHT GUIDE CATHETER; ABBOTT VISTA BRIGHT GUIDE CATHETER; ABBOTT VISTA BRIGHT GUIDE CATHETER
• Patient Age: 52 YR