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

Model Number 10666

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that vessel obstruction occurred.Vascular access was obtained via the femoral artery.During the procedure a 32 x 2.50 promus premier select drug-eluting stent was successfully placed in the right coronary (rca) artery.The physician then decided to treat the 80% stenosed, 28 x 2.50mm, de novo target lesion in the mildly tortuous and moderately calcified left anterior descending (lad) artery.The lad was predilated and a 32 x 2.75 promus premier select drug-eluting stent was deployed at high pressure.At this point, the physician noticed the left circumflex (lcx) had become pinched and there was no flow.The physician used a 28 x 2.50 promus premier select drug-eluting stent to treat the area of no flow in the lcx.No further patient complications were reported and the patient status was stable.

• Brand Name: PROMUS PREMIER SELECT
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10279012
• MDR Text Key: 199065615
• Report Number: 2134265-2020-09368
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2021
• Device Model Number: 10666
• Device Catalogue Number: 10666
• Device Lot Number: 0024423922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• 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: 60 YR