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

Catalog Number	RSINT40038UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/31/2019
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
During a procedure a resolute integrity rx coronary, drug eluting stent was used to treat a lesion in the mid left anterior descending(lad) artery.The device was inspected with no issues noted.Negative prep was not performed.It is reported that an expired stent was implanted in the patient.The product expired on the 25th of may 2019.The patient is alive with no injury.No intervention as a result of expired product.However it was reported that the patient also received a rsint40038ux also in the mid lad.The patient was noted to have a perforation of the artery after second stent deployment.Two non-medtronic covered stents were placed in the mid lad during this case.Pt remained in the hospital over the weekend and returned to cath lab for repeat angiography.Patient was noted to have inadequate sealing of perforation.A 4.0 non-medtronic stent was placed, patient left lab in stable condition.Md that performed intervention states patient ¿doing well¿.
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: 8757265
• Report Number: 9612164-2019-02670
• Device Sequence Number: 16775044
• Product Code: NIQ
• UDI-Device Identifier: 00643169037267
• UDI-Public: 00643169037267
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2019
• Device Catalogue Number: RSINT40038UX
• Device Lot Number: 0008780450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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: Required Intervention