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

Model Number 10665

Device Problems Failure to Advance (2524); Material Deformation (2976); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Date of event: the event date was not reported.The first date of the month of the aware date was used as an approximate.

Event Description

Reportable based on analysis completed (b)(4) 2018.The device was returned with no allegations of an adverse event or malfunction.Analysis of the returned device revealed stent damage.A promus premier select, mr, ous 4.00 x 24 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent was severely damaged and pulled distally on the balloon.The stent outer diameter at the time of manufacture was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip showed no signs of damage.Dried media was evident in the inflation lumen.The device was attached to an inflation device and pressure was increased 16 atmospheres as per directions for use however the balloon failed to inflate.The device was soaked in water bath and when the device was taken out of the water bath the balloon had fully inflated.No leaks were present.The balloon deflated in six seconds which is within specifications.The inflation device was verified before and after use using a druck pressure gauge.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues along the midshaft, inner or outer shaft polymer extrusion.

Manufacturer Narrative

Device is a combination product.Date of event: the event date was not reported.The first date of the month of the aware date was used as an approximate.Device evaluated by mfr: a promus premier select, mr, ous 4.00 x 24 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent was severely damaged and pulled distally on the balloon.The stent outer diameter at the time of manufacture was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip showed no signs of damage.Dried media was evident in the inflation lumen.The device was attached to an inflation device and pressure was increased 16 atmospheres as per directions for use however the balloon failed to inflate.The device was soaked in water bath and when the device was taken out of the water bath the balloon had fully inflated.No leaks were present.The balloon deflated in six seconds which is within specifications.The inflation device was verified before and after use using a druck pressure gauge.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues along the midshaft, inner or outer shaft polymer extrusion.

Event Description

Reportable based on analysis completed 21 september 2018.The device was returned with no allegations of an adverse event or malfunction.Analysis of the returned device revealed stent damage.It was further reported the stent damage occurred during the procedure.

Event Description

The device was returned with no allegations of an adverse event or malfunction.Analysis of the returned device revealed stent damage.It was further reported the stent damage occurred during the procedure.The lesion was lightly tortuous, and 80% stenosed and located in the heavily calcified stenosis of the right coronary artery stenosis.The lesion was pre-dilated with a 3.5mm nc emerge balloon catheter.Then, a promus premier select stent was not able to be positioned due to high resistance in the lesion.The lesion was again pre-dilated with a 3.5mm nc emerge and a second promus premier select stent was advanced and would not cross the lesion.Stent damage occurred to both promus premier select stents while experiencing high resistance at the lesion, during the procedure.The procedure was completed with a 4.0 x 28mm stent.

Manufacturer Narrative

Correction to remove the following statement; reportable based on analysis completed 21 september 2018.Additional procedural information added.Correction to date rec'd by mfr on the initial report from 09/21/2018 to 08/28/2018.Device is a combination product.Device evaluated by mfr: a promus premier select, mr, ous 4.00 x 24 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent was severely damaged and pulled distally on the balloon.The stent outer diameter at the time of manufacture was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip showed no signs of damage.Dried media was evident in the inflation lumen.The device was attached to an inflation device and pressure was increased 16 atmospheres as per directions for use however the balloon failed to inflate.The device was soaked in water bath and when the device was taken out of the water bath the balloon had fully inflated.No leaks were present.The balloon deflated in six seconds which is within specifications.The inflation device was verified before and after use using a druck pressure gauge.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues along the midshaft, inner or outer shaft polymer extrusion.

• 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: 7978843
• MDR Text Key: 124134604
• Report Number: 2134265-2018-61604
• 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
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: 10665
• Device Catalogue Number: 10665
• Device Lot Number: 0021342188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1