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

Model Number H7493925120400

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was reported that vessel perforation occurred.The 75% stenosed target lesion was located in the severely tortuous and severely calcified left main artery to proximal left anterior descending (lad) artery.A 20 x 4.00 promus premier¿ drug eluting stent was advanced to treat the lesion.When the stent was placed, a vessel perforation occurred.After insertion of an intra-aortic balloon pump (iabp), hemostasis was performed with a balloon and at the same time, a pericardial puncture was performed.Subsequently, a ¿cover stent¿ was then deployed and the procedure was completed.The next day, the iabp was removed.Eight days post procedure, the patient was discharged.The patient's status was stable.It was noted intravenous ultrasound (ivus) had not been performed prior to stent placement, and choosing an oversized stent had been suspected as the cause of the event.

• 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: 6746455
• MDR Text Key: 81129039
• Report Number: 2134265-2017-07471
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493925120400
• Device Catalogue Number: 39251-2040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR