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

Model Number 9315

Device Problem Material Integrity Problem (2978)

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

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device is a combination product.Device evaluated by mfr.: promus element,mr,ous 2.75x38mm stent delivery system was returned for analysis.Device returned with mandrel and stent protector attached.Removed without issue.A visual examination of the stent found stent damage.Stent strut damage in midsection of stent, struts lifted.The undamaged stent outer diameter was measured and the result was within max 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 signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks as well as a break at the distal end of the strain relief.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 10jun2020.It was reported that shaft damage occurred.Vascular access was obtained via the right femoral artery.The 80% stenosed, 32mm x 2.75mm, concentric, de novo target lesion with a bend of >45 and <90 degrees was located in severely tortuous and moderately calcified right coronary artery (rca).After a 6f jr non-bsc guide catheter and a non-bsc guide wire crossed the lesion, predilation was performed with a 2x12mm maverick balloon catheter resulting to 40% residual stenosis.A 2.75x38mm promus element drug-eluting stent was advanced for treatment.However, when the physician was trying to take the device in a challenging rca, the hypotube was damaged and it could be not moved forward.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the result was good with good timi 3 flow.The patient was moved to the intensive care unit safely.However, returned device analysis revealed stent damaged.

• 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: 10213616
• MDR Text Key: 196996998
• Report Number: 2134265-2020-08019
• 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: 06/30/2020

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: 05/25/2020
• Device Model Number: 9315
• Device Catalogue Number: 9315
• Device Lot Number: 0023027511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2018
• 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: 63 YR