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

Model Number H7493925138350

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4) device evaluated by mfr.: promus premier mr, ous, 3.5x38mm, stent delivery system was returned for analysis.A visual examination of the crimped stent found that the mid to distal end of the crimped stent was stretched and damaged.As a result the distal end of the stent was pulled out beyond the tip of the catheter.The undamaged stent outer diameter was measured which is within the maximum crimped stent specification.As part of the examination, the balloon was inflated to its rated burst pressure with no restrictions noted.No issues were observed with the balloon wall.The undamaged section of the stent (that was positioned over the balloon) deployed with no issue.It was not possible to deploy the stent for its entire length as the distal end of the stent was damaged and pulled over the tip and not placed over the balloon.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found a hypotube kink 9.2 cm distal to distal end of strain relief.This most likely occurred during handling of the device during the procedure.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found damage to the tip.The type of damage evident is consistent with resistance being encountered during advancement.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 and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on analysis completed on 31-jan-2018.It was reported that the stent failed to deploy.The target lesion was located in a coronary artery.A 38x3.50mm promus premier¿ drug-eluting stent was advanced for treatment.However, it was noted that stent could not be deployed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7282993
• MDR Text Key: 100657004
• Report Number: 2134265-2018-01078
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Model Number: H7493925138350
• Device Catalogue Number: 39251-3835
• Device Lot Number: 20671943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2017
• 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