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 Embolism (1829); Thrombus (2101)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: restenosis rates after drug-eluting stent treatment for stenotic small-diameter renal arteries.Title: cardiovascular and interventional radiology year: 2019 ref: https://doi.Org/10.1007/s00270-019-02264-z.Average age, majority,gender.Date of publication.Concomitant medical products: statins, antiplatelet agents, angiotensin-converting enzyme inhibitors (aceis), and angiotensin receptor blockers (arbs).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in a journal article that 37 patients in a study from june 2004 to may 2017 received drug eluting stents to treat main and segmental renal artery stenosis.Among these stents one resolute integrity rx drug eluting stent was used.The device was successfully implanted.Adverse events experienced included in-stent restenosis, all cause death, renal artery embolization, in situ thrombosis.Both the thrombus and the embolism were successfully treated with intra-arterial thrombolysis with tissue plasminogen activator.It was reported that one death occurred within 30 days, which was not related to the renal artery stent procedure.

• 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: 9178499
• MDR Text Key: 161991323
• Report Number: 9612164-2019-04312
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR