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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Myocardial Infarction (1969); Occlusion (1984); Cardiogenic Shock (2262); Stenosis (2263); Reaction (2414)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

Literature review: doi: 10.1016/j.Carrev.2016.12.020.

Event Description

One cocr zotarolimus-eluting stent (zes) was implanted in the proximal to mid rca to treat the restenosis.Four overlapped cocr zes were also implanted from the mid lad to left main to treat restenosis.Six months later, patient presented with severe restenosis at both vessels.Due to recurrent and aggressive restenosis, metal allergy was suspected.The patient revealed previous contact dermatitis and a specific test confirmed nickle allergy.After the finding, pci with paclitaxel eluting balloons was performed with good final result.Six months later, a cardiac tomography scan revealed severe anterior ischemia.Coronary angiography revealed critical restenosis at ostial lad, and severe restenosis at mid lad with an occluded distal vessel.The rca presented a moderate restenosis at mid and distal segment.Coronary artery bypass grafting (cabg) was performed with a left internal mammary artery (lima) to cx and with saphenous vein graft (svg) to the posterolateral branch of the rca.Two months later, the patient presented a non st elevation myocardial infarction complicated with cardiogenic shock.An emergent ca showed an occlusive restenosis of ostial lad and proximal rca and a critical stenosis of the ostial cx, svg was occluded.Pci was carried out using bioresorbable vascular scaffold (bvs) at lm-cx and a prescription of prednisolone daily.After six months, patient remains asymptomatic.Angiographic follow-up showed neither restenosis nor thrombosis of bvs and improvement of collateral circulation to rca and lad.

• Brand Name: RESOLUTE INTEGRITY 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: 7114871
• MDR Text Key: 94786135
• Report Number: 9612164-2017-01925
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P110013
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR