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

Model Number 9550

Device Problem Activation Failure (3270)

Patient Problem Chest Pain (1776)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

A4: weight: 67.5 kg.E1: initial reporter address 1:(b)(6).E1: initial reporter phone: (b)(6).

Event Description

It was reported that stent partial deployment occurred and the patient experienced chest tightness.The 90% stenosed, 20mm long and 3.0mm vessel diameter target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 20 x 3.00 promus premier ous mr drug eluting stent was advanced into the bifurcated lesion for treatment.However, during the procedure when pressure was applied, the proximal end of the stent inflated but the distal end could not be inflated.As a result, the patient experienced chest tightness.The balloon pressure was released, and the stent was pulled out after repeated pushing and pulling.The procedure was completed with another of the same device.The patient status was stable following the procedure.

• Brand Name: PROMUS PREMIER
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16957959
• MDR Text Key: 315532670
• Report Number: 2124215-2023-23193
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0028792069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male