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

Model Number H7493925128270

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the stent was deployed prematurely.The target lesion was located in the moderately tortuous and moderately calcified mid-left circumflex artery (lcx).A 28 x 2.75mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion completely after several attempts.When the device was removed, resistance was felt.The stent was then deployed covering 50% of the lesion and plain old balloon angioplasty (poba) was performed for the rest of the lesion and the procedure was completed.No patient complications were reported and the patient's status was stable.Patient doing well.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6751723
• MDR Text Key: 81320684
• Report Number: 2134265-2017-07607
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• 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: 07/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2018
• Device Model Number: H7493925128270
• Device Catalogue Number: 39251-2827
• Device Lot Number: 19662046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• 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): Other