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

Model Number 9392

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.A promus element plus,mr,ous 2.25x32mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Microscopic analysis showed evidence of stent damage to most distal stent strut.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon was 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 tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the shaft polymer extrusion found marker band damage to the distal marker band.An examination of the distal tip found no issues.The device was soaked at 37 degrees because the test guidewire could not track due to residue inside the guidewire lumen.The device was removed from the bath but the recommended 0.014 inch guidewire could not be advanced.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 25-jun-2020.It was reported that advancing difficulties were encountered.The target lesion was located in the severely tortuous and calcified left circumflex artery.A 2.25x32mm promus element plus drug-eluting stent was advanced but failed to reach the lesion.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.However, returned device analysis revealed stent damage.

• 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: 10274027
• MDR Text Key: 198876093
• Report Number: 2134265-2020-08897
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: 9392
• Device Catalogue Number: 9392
• Device Lot Number: 0023809107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 58