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 Vascular Dissection (3160)

Event Date 04/04/2024

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).The lesion was pre-dilated with a 2.75 x 12 mm semi-compliant balloon.A 2.75 x 28 mm promus elite was first deployed in the left circumflex (lcx) followed by a 3.00 x 38 mm promus elite in the lad at 11 atm.After post dilation of the 3.00 x 38 mm promus elite with a 3.50 x 12 mm non-compliant balloon, a distal edge, flow limiting dissection was noted.To cover the dissection, a 3.50 x 12 mm promus elite was deployed and the procedure was completed.The patient fully recovered and was stable post procedure.

• 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: 19106730
• MDR Text Key: 340223229
• Report Number: 2124215-2024-22648
• 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
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0032393675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention