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

Model Number 10677

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported that plaque shift occurred.The 80% stenosed target lesion was located in a moderately tortuous and non-calcified left anterior descending artery.A 38 x 3.50 promus elite drug-eluting stent (des) was advanced to treat the lesion.However, as the stent was being advanced, soft plaque was shifted distally.The device was removed and the procedure was completed with a 3.50x48 synergy des.There were no further patient complications.

Event Description

It was reported that plaque shift occurred.The 80% stenosed target lesion was located in a moderately tortuous and non-calcified left anterior descending artery.A 38 x 3.50 promus elite drug-eluting stent (des) was advanced to treat the lesion.However, as the stent was being advanced, soft plaque was shifted distally.The device was removed and the procedure was completed with a 3.50x48 synergy des.There were no further patient complications.

Manufacturer Narrative

The promus elite ous mr 38 x 3.50mm stent delivery system was returned for analysis.No issues were identified during analysis of the device.Visual/tactile examination of the device revealed no issues were with the hypotube shaft, stent, or the outer / mid-shaft sections or the inner lumen of the device.Microscopic examination revealed no issues with the stent; there was no sign of damage, stretching or lifting of the stent struts.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and had not been subjected to positive pressure.There were no signs of movement; the stent was set between the proximal and distal markerbands.The bumper tip showed no signs of distal tip damage.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16824913
• MDR Text Key: 314109084
• Report Number: 2124215-2023-19304
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0027258942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• 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 Outcome(s): Other
• Patient Race: Asian