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

Model Number H7493925128250

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).

Event Description

It was reported that stent damage occurred.The 80-85% stenosed target lesion was located in the moderately calcified left anterior descending artery.A 28 x 2.50mm promus premier¿ drug-eluting stent was advanced for treatment; however, friction was encountered while trying to pass the lesion.When the device was removed, it was noted that some struts at the proximal section were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.The 80-85% stenosed target lesion was located in the moderately calcified left anterior descending artery.A 28 x 2.50mm promus premier¿ drug-eluting stent was advanced for treatment; however, friction was encountered while trying to pass the lesion.When the device was removed, it was noted that some struts at the proximal section were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: promus premier ous mr 2.50 x 28mm stent delivery system was returned for analysis.The stent was not returned for analysis.The manufacturing crimp data for this device was reviewed and there were no anomalies noted.From the manufacturing data the maximum stent profile was within the maximum crimped stent profile measurement.The balloon was reviewed and there were no issues to note.The balloon cones were folded and there were crimp markings evident on the balloon body indicating overall crimp contact between the stent and the balloon at the time of manufacture.A visual and tactile examination of the device revealed no issues.An examination of the inner and outer shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were noted.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7641590
• MDR Text Key: 112455483
• Report Number: 2134265-2018-05587
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2019
• Device Model Number: H7493925128250
• Device Catalogue Number: 39251-2825
• Device Lot Number: 21242507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1