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

Model Number 9315

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus element, mr, ous 3.00 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent struts were damaged on the mid-section of the stent (rows 8-17 counting from proximal end), struts were lifted and pulled distally.The undamaged section of the crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 06apr2020.It was reported that shaft kink occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 32x3mm, concentric, de novo target lesion was located in the severely tortuous and mildly calcified left circumflex artery.The lesion contained >45 and <90 degrees bend.Pre-dilation was performed using a 2x12mm maverick balloon catheter, leaving 40% residual stenosis in the lesion.A 3.00x38mm promus element long drug-eluting stent was advanced for treatment but the hypotube was kinked badly and unable to proceed further to the lesion.The procedure was completed with another of same device and was post-dilated with a 3x8mm nc emerge balloon catheter.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• 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: 10004931
• MDR Text Key: 189613034
• Report Number: 2134265-2020-05046
• 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: 04/28/2020

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: 03/25/2020
• Device Model Number: 9315
• Device Catalogue Number: 9315
• Device Lot Number: 0022752629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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
• Patient Age: 56 YR