MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING

Model Number 10672

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.A 16 x 3.50mm promus elite stent delivery system was returned for analysis.A visual (via scope) examination of the crimped stent found no issues with 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 between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured by snap gauge and was within max crimped stent profile measurement.A visual examination (via scope) of the balloon sections found no issues.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual (via scope) and tactile examination of the hypotube found a hypotube break 23.6cm distal to distal end of strain relief (proximal of shaft markers), slight bending of the hypotube was noted on both sides of break.Multiple hypotube kinks were also noted along length of hypotube.A visual (via scope) and tactile examination of the shaft polymer extrusion found no issues.A visual (via scope) examination of the tip found no issues with the tip.The device was loaded onto and tracked over a 0.014 inch guidewire without issue.

Event Description

Reportable based on analysis completed on 20sep2019.It was reported that the stent was partly broken.A percutaneous transluminal coronary intervention was being performed.The 16mm x 3.5mm promus elite stent was used during the procedure and was reported to be partly broken.The procedure was successfully completed with a different device without issue or patient injury.However, returned device analysis revealed shaft break.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9175612
• MDR Text Key: 162857316
• Report Number: 2134265-2019-12073
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10672
• Device Catalogue Number: 10672
• Device Lot Number: 0023699462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• 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