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

Model Number 10676

Device Problem Failure to Advance (2524)

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

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: p elite ous mr 32 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.The entire stent had moved proximally on the balloon with the stent struts lifted and stretched proximally extending towards the bi-component bond.It was not possible to obtain an undamaged stent.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 along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found issues with bunching noted of the blue inner lumen 78mm proximal to the distal tip.Additionally, stretching and damage was observed along the length of the shaft polymer extrusion section of the delivery shaft.

Event Description

Reportable based on device analysis completed on 28-oct-2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via femoral artery.The target lesion was located in the mildly calcified coronary artery containing a <=45 degrees bend.A 32 x 3.00 promus elite drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No known patient complications were reported.However, returned device analysis revealed a stent damage.

• 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: 10845202
• MDR Text Key: 216419522
• Report Number: 2134265-2020-15760
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 10676
• Device Catalogue Number: 10676
• Device Lot Number: 0023706566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• 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