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

Catalog Number	RSINT35022UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	08/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
Patient had two resolute integrity stents implanted during the index procedure.Three days post procedure, the patient began experiencing symptoms including a rash on the leg and then a scab on the foot.The patient has experienced constant itch terribly since then.It was reported that the patient also developed cellulitis and has been hospitalized because of the rash and on prednisone ever since.It is believed that the rash is related to the stent implantation.Patient is still being tested but the symptoms are reducing or being better managed.
Additional Manufacturer Narrative
It was confirmed that the patient was cathed one year later and had no complaints at that time, no mention of rashes or nickel content at the time.The stents were open and it was a successful follow up.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6656122
• Report Number: 9612164-2017-00783
• Device Sequence Number: 1541307
• Product Code: NIQ
• UDI-Device Identifier: 00643169037137
• UDI-Public: 00643169037137
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2017

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: 04/08/2017
• Device Catalogue Number: RSINT35022UX
• Device Lot Number: 0007532898
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/10/2017; 07/10/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/03/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization