MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RX; STENT, CORONARY, DRUG-ELUTING

Lot Number UNKNOWN

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 06/01/2008

Event Type  Injury  

Manufacturer Narrative

A completely fractured zotarolimus-eluting stent in an aortocoronary saphenous vein bypass graft.Doi 10.1002/ccd.24312.Still procedural images show- svg-d-om bypass graft after deployment of a endeavor zotarolimus-eluting stent for in-stent restenosis.Images also show evidence of a highly mobile svg-d-om bypass with a complete fracture of a zotarolimus-eluting stent at the ostium and svg-d-om bypass with restored timi 3 flow after percutaneous intervention that included removal of the proximal section of the fractured stent from the bypass.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient had 3 non medtronic stents implanted to the ostium of the svg-d-om bypass (b)(6) 2004.On (b)(6) 2007 the patient returned with unstable angina that required deployment of a non medtronic stent to treat the ostium of the svg-d-om bypass for the first episode of in-stent restenosis.On (b)(6) 2008 the patient was admitted with unstable angina and diagnosed with a second episode of ostial svg-d-om bypass graft in-stent restenosis.During revasc procedure, an endeavor zes was implanted to treat restenosis.The stent was deployed at 16atm for 25 seconds and post-dilated at 21 atm for 30 seconds with 0% post-procedure stenosis.85 days later ((b)(6) 2018) post implant of endeavor rx drug eluting stent, the patient was re-admitted with chest pain and a non stemi.Total occlusion was noted of the previously treated svg-d-om bypass with total occlusion and evidence of proximal fracture in a highly dynamic portion of the vessel.2 sprinter balloons were used to dilate the area of instent restenosis distal to the stent fracture and the proximal stent fracture area itself.The guidewire, balloon and guide catheter were removed together restoring of thrombolysis in myocardial infarction (timi flow 3) in the bypass graft.The proximal section of the fractured stent was reported to have dislodged at the femoral artery sheath level.Vascular surgery evaluation located the dislodged fragment in a branch of the right femoral profundis artery.It was decided to leave the stent fragment in the femoral profundis branch.The patient recovered without any issue and discharged from hospital 2 days later.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDEAVOR RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8586288
• MDR Text Key: 144267997
• Report Number: 9612164-2019-01602
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060033
• 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,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 05/07/2019
• 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: 76 YR