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

Model Number H7493925128250

Device Problems Bent (1059); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr:  it is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent foreshortening occurred.Vascular access was obtained via the right femoral artery.The 70% stenosed, 26mm in length, eccentric, de novo target lesion was located in the mildly tortuous, moderately calcified ad 2.5mm in diameter left anterior descending artery.A 28 x 2.50 promus premier¿ drug-eluting stent was deployed to treat the lesion.However, upon removing the delivery balloon, it was visualized that the proximal marker moved far away from the proximal end of the stent but the distal marker only moved a short distance away from the distal end of the stent, which meant that the stent had foreshortened.The procedure was completed with pre-dilatation and with another promus stent.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: 7321118
• MDR Text Key: 101770884
• Report Number: 2134265-2018-01527
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BN
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: H7493925128250
• Device Catalogue Number: 39251-2825
• Device Lot Number: 0021336530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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
• Treatment: GUIDE CATHETER: 6F LAUNCHER EBU 3.5; GUIDE WIRE: ASAHI SION BLUE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR