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

Model Number RSINT30015W

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

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It is reported that a patient had two resolute integrity drug-eluting stents implanted.It is reported that the patient was having breakouts and a rash that was getting worse, since having the devices implanted.It is stated that the patient had tested positive for allergies to nickel and chromium.

Manufacturer Narrative

Additional information: two resolute integrity drug-eluting stents implanted (2018).The official diagnosis was that there was an allergic reaction.The patient's dermatologist indicated there was a sensitivity to nickel and chromium while the patient's cardiologist indicated that it was an autoimmune reaction.The patient is currently managing their symptoms and is receiving treatment for the breakouts and rash with medication and topical cream.The patient's symptoms have decreased after follow-up with physician.It was stated that other infections occurred in (b)(6) 2018 with these becoming worse in (b)(6) 2018.The patient had a further 4 stents implanted around 20 years ago and also had 2 stents in 2017.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RESOLUTE INTEGRITY OTW
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9726657
• MDR Text Key: 188066288
• Report Number: 9612164-2020-00790
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00613994793416
• UDI-Public: 00613994793416
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2019
• Device Model Number: RSINT30015W
• Device Catalogue Number: RSINT30015W
• Device Lot Number: 0008682413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 68