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

Model Number	INT30009UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During the index procedure, two integrity stents were implanted in the rca and one resolute onyx rx drug eluting stent in the 1st obtuse marginal.Approximately 12 months post index procedure, the patient suffered nstemi.The patient was treated with medication and the event remains unresolved, continuing with treatment.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The integrity rx devices previously reported were never implanted in patient.The resolute onxy is the only stent implanted in patient.
Additional Manufacturer Narrative
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: 6390799
• Report Number: 9612164-2017-00255
• Device Sequence Number: 565661
• Product Code: MAF
• UDI-Device Identifier: 00613994798473
• UDI-Public: 00613994798473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2017

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: 06/15/2017
• Device Model Number: INT30009UX
• Device Catalogue Number: INT30009UX
• Device Lot Number: 0007616092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 02/20/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 03/10/2017; 03/24/2017; 10/02/2017
• 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: Life Threatening
• Patient Age: 78 YR
• Patient Weight: 89