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

Catalog Number UNK-CV-GWY-INT-DES

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

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Pain (1994); Reaction (2414); Blood Loss (2597)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient had a resolute integrity rx drug eluting stent implanted without any reported issue.Patient reported that they have experienced a number of negative symptoms ever since their resolute integrity stent was implanted: loss of eyesight, pain in wrist (site of catheter insertion), infection in their body that is affecting their bladder and kidneys, breathing problem (about 3 times per hour the patient gasps for air), cramping in muscles, skin is dried out, fatigue and headaches, nerve and joint pain, swollen ankles, and they can taste aluminium or copper in their mouth.They said that 4 hours after the stent was implanted they were hospitalised due to haemorrhaging.Patient was hospitalized for 9 days after this and passed two blood clots.Patient noted that they has been hospitalised almost every month since the stent was implanted.Patient noted that they had other stainless steel stents implanted, but didn't have any side effects from those.Patient has an appointment to see their cardiologist.

• 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: 7994734
• MDR Text Key: 124679216
• Report Number: 9612164-2018-02880
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-INT-DES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• 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