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

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

Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888); Occlusion (1984); Thrombus (2101); Stenosis (2263); Injury (2348)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: comparison of drug eluting versus bare metal stents for pulmonary vein stenosis in childhood journal: catheterization and cardiovascular interventions year: 2019 ref: doi: 10.1002/ccd.28328.Death was reported as a clinical outcome of this study, however there is no information to suggest the device has caused or contributed to a death.Additional codes: c50616 and c50678.Medication: antiplatelet therapy, aspirin.If information is provided in the future, a supplemental report will be issued.

Event Description

A retrospective review of all stent implants for pulmonary vein stenosis (pvs) between august 1993 and november 2017 was conducted in this study.Resolute integrity rx coronary drug eluting stents were among the 111 drug eluting stents implanted in 41 patients to treat 105 lesions.Prior to implantation of stents, resistant lesions were prepared to abolish any residual waist.All patients were started on antiplatelet therapy within 24 hr of stent implant unless a contraindication existed.Post implantation three major complications were reported; bleeding in the endotracheal tube related to mechanical trauma during transfer, thrombus in the distal vein post stent implantation treated with aspiration thrombectomy and pulmonary haemorrhage noted a few days after catheterization.Initial and long term follow-up catheterizations included stent re-dilations, distal lesions treated with angioplasty and placement of new stents, lesions with repeat stenting with des for restenosis and complete occlusion.Multiple stents were intentionally fractured on follow-up catheterization to achieve diameter >6 mm.10 patient deaths were reported.Medtronic judkins right guide catheters were used during the procedures.No alleged product issue or adverse events reported for these devices.

• 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: 9197768
• MDR Text Key: 162825896
• Report Number: 9612164-2019-04386
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2019
• 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: 8 MO
• Patient Weight: 6