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

Model Number 9384

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a promus element plus, mr, ous 2.75x16mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured and the result was within maximum crimped stent profile measurement.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 microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found a break 19.5cm distal to the distal end of the strain relief as well as multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during analysis.

Event Description

Reportable based on device analysis completed on 02-oct-2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 85% stenosed, 3mm x 28mm, concentric target lesion containing a >45 and <90 degrees bend was located in the mildly tortuous and mild to moderately calcified right coronary artery.A 2.75x16mm promus element plus drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a different device.There were no patient complications reported.However, returned device analysis revealed hypotube shaft break.

• Brand Name: PROMUS ELEMENT PLUS
• 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: 10726131
• MDR Text Key: 212718162
• Report Number: 2134265-2020-14667
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: 9384
• Device Catalogue Number: 9384
• Device Lot Number: 0024534245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• 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