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

Model Number H7493952820220

Device Problems Difficult To Position (1467); Sticking (1597); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2017

Event Type  malfunction  

Event Description

Attempted to deploy stent several times.Stent was advanced into artery but was unable to cross lesion.After several attempts, stent eventually became dislodged and stuck inside guide hub.All supplies were removed from patient's body and dislodged stent was recovered from guide catheter.No harm was caused to patient.

• Brand Name: PROMUS PREMIER¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7137581
• MDR Text Key: 95480348
• Report Number: 7137581
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/24/2019
• Device Model Number: H7493952820220
• Device Catalogue Number: H7493952820220
• Device Lot Number: 20969493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN WHICH DEVICES WERE BEING USED
• Patient Age: 63 YR