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

Catalog Number	INT40009UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/03/2017
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 the index procedure, a resolute integrity drug eluting stent was implanted in the rca.Approximately 26 months post procedure, a revascularization was carried out during which two integrity bare metal stents were implanted in the lcx.The following day, the patient suffered troponin elevation.Cec adjudicated event as a non-q-wave mi of non-target vessel.Cec also adjudicated stent thrombosis as non-event.
Additional Manufacturer Narrative
Event date corrected to (b)(6) 2017.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: 7951663
• Report Number: 9612164-2018-02691
• Device Sequence Number: 11144315
• Product Code: MAF
• UDI-Device Identifier: 00613994798619
• UDI-Public: 00613994798619
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: 08/29/2018
• Device Catalogue Number: INT40009UX
• Device Lot Number: 0008192114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 75