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

Catalog Number	RSINT30022UX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A resolute integrity rx coronary drug eluting stent was used to treat a non tortuous, non calcified lesion located in the mid lad.The device was inspected with no issues.It was reported that the stent was implanted in the patient 7 hours after its expiration date.It is indicated that it is unknown how the product was on the shelf for use as product near expiry date is pulled and put in the inventory office to be checked out.No patient injury is reported.
Additional Manufacturer Narrative
The patient presented with stemi in the early hours of the morning.The lesion was in the mid lad.The lesion was pre-dilated.No medical or surgical intervention (e.G.Antibiotics) was required as a result of this event.Patient was fine after the procedure.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: 8118993
• Report Number: 9612164-2018-03427
• Device Sequence Number: 16193605
• Product Code: NIQ
• UDI-Device Identifier: 00643169037168
• UDI-Public: 00643169037168
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• 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): 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: RSINT30022UX
• Device Lot Number: 0008242214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR