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

Model Number H7493925132250

Device Problems Bent (1059); Difficult to Insert (1316); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 75% stenosed target lesion was located in a mildly tortuous and moderately calcified vessel.Pre-dilatation was performed.A 32mm x 2.50mm promus premier¿ stent delivery system (sds) was selected and advanced; however, the device was unable to cross the target lesion.When the device was removed from the patient, it was noted that the stent was slightly lifted.The physician attempted to insert the sds into a non-bsc guide catheter extension; however, the device failed to insert into the proximal port of the guide catheter extension.Replacing the non-bsc guide catheter extension did not resolve the issue.It was determined that unsuccessful insertion caused the lifted stent.The procedure was completed with another promus premier stent.No patient complications were reported.

Manufacturer Narrative

(b)(4).Device is a combination product.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system was returned for analysis.The tip of the device was slightly flared.This type of damage is consistent with the device meeting an obstruction during an attempt to cross a lesion.A visual and microscopic examination found no issue with the profile of the device¿s inner or markerbands.A visual and microscopic examination of the stent found that the struts on the most distal row were slightly raised off the balloon material.The proximal side of the strut was raised which would indicate that this damage occurred during the withdrawal of the device.The balloon was visually and microscopically examined and no issues were noted with its profile that could have potentially contributed to the complaint incident.The balloon was tightly wrapped, evenly folded and was not subjected to positive pressure.A visual and tactile examination found no issue with the shaft polymer extrusion profile.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: ¿an unexpanded stent should be introduced into the coronary arteries one time only.An unexpanded stent should not be subsequently moved in and out through the distal end of the guide catheter as stent or coating damage or stent dislodgment from the balloon may occur¿.(b)(4).

Event Description

It was reported that stent damage occurred.The 75% stenosed target lesion was located in a mildly tortuous and moderately calcified vessel.Pre-dilatation was performed.A 32mm x 2.50mm promus premier stent delivery system (sds) was selected and advanced; however, the device was unable to cross the target lesion.When the device was removed from the patient, it was noted that the stent was slightly lifted.The physician attempted to insert the sds into a non-bsc guide catheter extension; however, the device failed to insert into the proximal port of the guide catheter extension.Replacing the non-bsc guide catheter extension did not resolve the issue.It was determined that unsuccessful insertion caused the lifted stent.The procedure was completed with another promus premier stent.No patient complications were reported.

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4828334
• MDR Text Key: 15231694
• Report Number: 2134265-2015-03424
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2015
• Device Model Number: H7493925132250
• Device Catalogue Number: 39251-3225
• Device Lot Number: 16874487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1