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

Model Number H7493925112300

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that premature deployment of the stent occurred.Vascular access was obtained via the femoral artery.The 95% stenosed, concentric target lesion was located in the moderately tortuous and moderately calcified, 3mm in diameter mid right coronary artery (rca).After pre-dilatation was performed, a 12 x 3.00 promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during placement of the stent, it was caught by the calcium deposits and could no longer move.The physician deployed the stent where it stopped and missed to cover the lesion.Subsequently, another stent was deployed to cover the lesion and the procedure was completed.No patient complications were reported and the patient's status was stable.

• 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: 6736883
• MDR Text Key: 80857378
• Report Number: 2134265-2017-07624
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2017
• Device Model Number: H7493925112300
• Device Catalogue Number: 39251-1230
• Device Lot Number: 18982832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• 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): Required Intervention