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

Model Number 10663

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

Patient Problem Chest Pain (1776)

Event Date 07/01/2023

Event Type  Injury  

Event Description

It was reported that stent recoiling occurred and additional intervention was required.The 90% stenosed target lesion was located in the moderately tortuous left anterior descending (lad) artery.Three drug eluting stents were deployed to treat the lesion: a 2.50 x 32 promus premier select in the distal lad, 3.00 x 38 promus premier select in the proximal-mid lad and 3.50 x 16 promus premier select in the left main lad.11 days later, the patient experienced chest pain.Angiogram revealed that recoiling occurred in the bifurcated area of the diagonal and ramus with the 2.50 x 32 promus premier select and 3.00 x 38 promus premier select.A drug eluted balloon was used in the recoiled area, followed by dilatation with a non-compliant balloon.The patient fully recovered.

Manufacturer Narrative

Initial reporter address 1: (b)(6) hospital.

• Brand Name: PROMUS PREMIER SELECT
• 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: 17438469
• MDR Text Key: 320200882
• Report Number: 2124215-2023-40832
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10663
• Device Catalogue Number: 10663
• Device Lot Number: 0030273390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: Asian