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

Model Number 9384

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  Injury  

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 16x4.00mm, concentric and the de novo target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.After a non-bsc guide wire crossed the lesion, predilation was performed with a non-bsc balloon catheter.A 4.00x16mm promus element plus drug-eluting stent was deployed in the lesion.However, after post dilation was performed using a 3.5x10mm nc non-bsc balloon catheter, the physician noted stent fracture in mid segment of the deployed stent.To cover the fractured stent, a short size stent was deployed and the procedure was completed.No further patient complications were reported and the patient's status was stable and responding well to medicines.

• Brand Name: PROMUS ELEMENT PLUS
• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7843385
• MDR Text Key: 119101850
• Report Number: 2134265-2018-60688
• 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: 09/04/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: 9384
• Device Catalogue Number: 9384
• Device Lot Number: 0020056884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2017
• 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: 58 YR