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

Model Number 10676

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

Patient Problem Vascular Dissection (3160)

Event Date 12/03/2022

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 32 promus elite was deployed.A dissection was noticed at the distal edge of the stent.An additional 2.75 x 20 promus elite was deployed distally to cover the dissection.The procedure was completed successfully and the patient fully recovered.

Event Description

It was reported that a dissection occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 32 promus elite was deployed.A dissection was noticed at the distal edge of the stent.An additional 2.75 x 20 promus elite was deployed distally to cover the dissection.The procedure was completed successfully and the patient fully recovered.It was further reported that a 2.75 x 12 semi-compliant balloon was used to pre-dilate the 90% stenosed, moderately tortuous and moderately calcified target lesion.The stent was fully deployed with no issues at 11 atm.A 3.00 x 12 non-compliant balloon was used to post-dilate the stent at 18 atm.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16009960
• MDR Text Key: 305752713
• Report Number: 2124215-2022-53404
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10676
• Device Catalogue Number: 10676
• Device Lot Number: 0029481127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Race: Asian