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

Catalog Number	RSINT40009UX
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blood Loss (2597); Patient Problem/Medical Problem (2688)
Date of Event	05/17/2016
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
A resolute integrity drug eluting stent was being used to treat a lesion in a patient.It was reported that the stent became stuck, caught in heart.The patient had to be transported to another facility where an emergency triple bypass surgery was carried out.Another stent was also placed during this surgery.Due to the loss of blood, the patient required a blood transfusion.Patient stated that they are on edge following the procedure and that scars are present on their legs due to graphs being required during the surgery.
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: 7442386
• Report Number: 9612164-2018-00830
• Device Sequence Number: 1511174
• Product Code: NIQ
• UDI-Device Identifier: 00643169037304
• UDI-Public: 00643169037304
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2017
• Device Catalogue Number: RSINT40009UX
• Device Lot Number: 0007612821
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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