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

Model Number H7493918408250

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Device is combination product.(b)(4).Device evaluated by mfr: the stent delivery system was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.A visual examination of the bumper tip showed no signs of damage.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 severe hypotube kinks along several locations of the hypotube shaft.This type of damage most likely occurred due to application of excessive force on the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft section found a kink in shaft polymer extrusion at 37 mm distal to wire exchange port and the core-wire was kinked at this site also.Another kink in mid-shaft extrusion at 39mm proximal to wire exchange port was also noted.The type of damages noted most likely occurred due to application of excessive force on the delivery system.The bicomponent bond showed no signs of damage or strain.Red substance (appeared to be blood) was also observed inside the balloon and outer extrusion lumen during device examination.As part of analysis, the device was loaded onto a recommended 0.014'' guidewire without issues.Leak test was performed by attempting to inflate the balloon to 18 atmospheres using an inflation device.The balloon did not inflate due to a shaft leak that was noted.A tear on the outer shaft polymer extrusion (longitudinal tear 2 mm in length) was observed at 74 mm distal to the wire exchange port (the tear was located 1258mm distal to the distal end of the strain relief).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

The target lesion was located in the distal rca.It was reported that there was a hole in the shaft of the promus element¿ plus, therefore the balloon could not be inflated for positioning of the stent.There were no patient complications related to this event and the procedure was completed with another of the same device.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 7496291
• MDR Text Key: 107719125
• Report Number: 2134265-2018-03678
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2019
• Device Model Number: H7493918408250
• Device Catalogue Number: 39184-0825
• Device Lot Number: 20930813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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
• Patient Age: 65 YR