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

Model Number H7493952820300

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Chest Tightness/Pressure (2463)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 stent fracture and in-stent restenosis occurred.In (b)(6) 2016, the patient presented with unstable angina and the index procedure was performed.The target lesion was located in the left main coronary artery (lmca).A 3.00x20mm promus premier¿ stent was implanted to treat the lesion.The patient tolerated the procedure well and one day post procedure, the patient was discharged.However, at around 11 pm on the same day, the patient presented back to the emergency department due to chest tightness and heaviness.On the following day, coronary angiogram was performed and it was noted that the previously placed 3.00x20mm promus premier¿ stent had fractured with 80% stenosis at the fracture site.The fractured stent was replaced with a 3.0 x 12 mm non-bsc stent.Final angiogram showed normal blood flow.The following day the patient was discharged.No further patient complications were reported.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5460992
• MDR Text Key: 39040061
• Report Number: 2134265-2016-01011
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2017
• Device Model Number: H7493952820300
• Device Catalogue Number: 39528-2030
• Device Lot Number: 18531566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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
• Patient Age: 75 YR