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

Model Number H7493918432300

Device Problems Bent (1059); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found slight stretching of the stent on the proximal side and over the proximal markerband.The bumper tip of the device showed no signs of damage.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found one hypo kink 44mm distal to the strain relief.This type of damage is consistent with excessive force being applied to the delivery system and may have occurred during attempts to track the device over the guidewire.A visual and tactile examination found compression failure damage (accordioned) on the inner lumen 73mm distal to the port weld as well as damage to the inner 5mm proximal to the bi-component bond where the lumen was bunched together.This type of damage is consistent with excessive tensile force being applied to the delivery system.A 0.014¿ guidewire was successfully inserted during analysis through the tip of the device with little resistance in the parts where the inner lumen was damaged.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 is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 29mar2016.It was reported that wire lumen restriction and catheter tip damage occurred.The target lesion was located in the severely calcified coronary artery.After pre-dilation was performed, the physician attempted to insert a 3.00x32mm promus element¿ plus stent on to the guidewire, but it failed.It was noted that the tip of the device was flattened.The procedure was completed with a 3.00x32mm promus premier stent.No patient complications were reported and the patient's status was good.However, device analysis revealed proximal stent damage.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5596616
• MDR Text Key: 43277753
• Report Number: 2134265-2016-03028
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2016
• Device Model Number: H7493918432300
• Device Catalogue Number: 39184-3230
• Device Lot Number: 17591708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2015
• 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