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 Intimal Dissection (1333); Stroke/CVA (1770); Congestive Heart Failure (1783); Hematoma (1884); Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Myocardial Infarction (1969); Occlusion (1984); Perforation (2001); Renal Failure (2041); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 09/30/2017

Event Type  Injury  

Manufacturer Narrative

Journal name: international heart journal title of article: three-year major clinical outcomes of angiography-guided single stenting technique in non-complex left main coronary artery diseases literature reference: doi:10.1536/ihj.17-115 received for publication february 24, 2017.Revised and accepted june 5, 2017.Released in advance online on j-stage september 30, 2017.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A 239 patients were enrolled to the study and divided into 2 sub-groups - angiography-guided pci and ivus-guided pci.The study population included 196 eligible patients with non-complex lmca disease treated with the single stenting technique using des.Resolute zotarolimus-eluting stents were implanted in the rca, ramus, lmca, lad and lcx during the study.Patients were administered unfractionated heparin pre-operatively.Peri-procedural complications reported in this study include: hematoma, pseudo-aneurysm, acute renal failure, congestive heart failure, stroke, dissection, perforation, occlusion and spasm.The cumulative incidence of various individual and composite clinical outcomes during the 3-year clinical follow-up was compared between the two groups.Clinical outcomes included death, myocardial infarction, revascularization, cerebral haemorrhage, septic shock and major adverse cardiac events.

• 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: 7111874
• MDR Text Key: 94630469
• Report Number: 9612164-2017-01897
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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

• 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
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/13/2017
• 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): Life Threatening
• Patient Age: 63 YR