MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Catalog Number	INT30015UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Reaction (2414)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A patient previously implanted with an integrity rx coronary bare metal stent queried what the stent was made of.It was reported that since having the stent implanted that itching has occurred and an occasional rash.Symptoms began within hours of having the stent implanted.The patient also started a blood thinner at the time of implant and is trying to determine if the medication or stent is causing the symptoms.The patient reports working with a dermatologist to determine the cause of itching and states that the dermatologist wanted to know what the stent was made out of.The material specifications of the stent were explained to the patient.
Additional Manufacturer Narrative
The patient had a dialysis stent previously implanted.The patient has no known allergies.The patient has occasional hives.The patient was given antihistamines which provided minor relief.The patient indicated that they get itchy when their phosphorus is high when on dialysis, and the symptoms started immediately after the patient was given plavix ¿ although they have continued on the prasugrel too.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTEGRITY RX
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8416052
• Report Number: 9612164-2019-00862
• Device Sequence Number: 1920892
• Product Code: MAF
• UDI-Device Identifier: 00613994798497
• UDI-Public: 00613994798497
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2019
• Device Catalogue Number: INT30015UX
• Device Lot Number: 0008699211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 63