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

Model Number 10673

Device Problems Defective Device (2588); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  Injury  

Event Description

It was reported that a stent damage occurred.Vascular access was obtained via the femoral artery.A percutaneous coronary intervention (pci) was preformed on a 95% stenosed, 15 x 3.5mm, concentric, de novo target lesion with less than or equal to 45 degree bend, concentric shape, located in the mildly tortuous and non-calcified mid left circumflex (lcx) artery.A semi compliant balloon was advanced to dilate the target lesion.Following predilatation, a 20 x 3.50 promus elite stent was advanced to the target lesion and deployed.It was noted that significant resistance occurred while advancing the device.Following stent deployment, a 12 x 3.5 nc balloon was used to dilate the lesion.Following post dilatation, distortion in the stent structure was observed on the distal part of the stent.Stent boost reconfirmed that the distal part of the stent appeared to be elongated and had lost its structure.Another stent device was advanced and deployed across the segment to complete the procedure.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10950504
• MDR Text Key: 219873888
• Report Number: 2134265-2020-16688
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 10673
• Device Catalogue Number: 10673
• Device Lot Number: 0025236377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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