MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING

Model Number UNK634

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Same case as mdr id # 2134265-2018-05797.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2012 a 3.5 x 32 mm promus element everolimus-eluting coronary stent system was implanted in the saphenous vein graft(svg) and in (b)(6) 2016 a 3.00 x 38 mm promus premier¿ stent was implanted partially overlapping the promus element.In (b)(6) 2018 the stents were noted to have restenosed.A 10 mm x 3.00 mm wolverine¿ coronary cutting balloon® monorail® was advanced in an attempt to dilate and failed to cross the isr.The procedure was completed with a different device.No further patient complications were reported.

• Brand Name: PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
• 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: 7645707
• MDR Text Key: 112583778
• Report Number: 2134265-2018-06112
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• 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): Required Intervention