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

Model Number H7493939928400

Device Problems Bent (1059); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.The target lesion was located in the calcified left anterior descending artery (lad).It was very difficult to advance a 4.00x28mm promus premier select stent to the lesion.It was noted that a stent strut was not in the right place.The procedure was completed with another promus premier select device.No patient complications were reported.The patient¿s status was fine.

Event Description

It was reported that stent damage occurred.The target lesion was located in the calcified left anterior descending artery (lad).It was very difficult to advance a 4.00x28mm promus premier select stent to the lesion.It was noted that a stent strut was not in the right place.The procedure was completed with another promus premier select device.No patient complications were reported.The patient¿s status was fine.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: a visual examination of the crimped stent found the first proximal stent row was damaged with the strut lifted on one side and pulled distally.Visual examination of the crimped stent found the first proximal stent row was damaged with the strut lifted on one side and pulled distally.This type of damage is consistent with the stent encountering resistance in an attempt to withdraw the device.The undamaged crimped stent od(outer diameter) was measured using snap gauge and the result was 0.0480¿¿, this is within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the device found no issue with the hypotube.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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7241424
• MDR Text Key: 99095929
• Report Number: 2134265-2018-00304
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: H7493939928400
• Device Lot Number: 0021420796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1