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

Model Number 9315

Device Problems Defective Device (2588); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the 1st day of the month of the bsc aware date since event date not provided.Device is a combination product.Device evaluated by mfr.: promus element, mr, ous 2.75 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.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 outer diameter was measured and the result is 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 damage.A visual and tactile examination of the hypotube found multiple kinks and a break 53.6cm distal to the distal end of the strain relief.A visual examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 08-oct-2019.It was reported that advancing difficulties were encountered and device was damaged.The target lesion was located in the left coronary artery.After engaging 6f extra back-up guide catheter and placing a guide wire, pre-dilatation was performed with a non-bsc balloon.A 2.75x38mm promus element drug-eluting stent was advanced but failed to track the lesion and it was noted that the distal portion was damaged.The device was removed and the procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed hypotube detachment.

• Brand Name: PROMUS ELEMENT LONG
• 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: 9234718
• MDR Text Key: 166589262
• Report Number: 2134265-2019-12797
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 9315
• Device Catalogue Number: 9315
• Device Lot Number: 0022860676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• 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