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

Model Number	INT30009UX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
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
During a procedure a integrity rx coronary bare metal stent was used to treat a lesion.The device was inspected with no issues.Negative prep was not performed.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.It is reported that the post op nurse discovered that the device had expired while reviewing the stent card.The device expired on the 11 april 2019 and was used in the patient on the (b)(6) 2019.The patient is alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
There was no patient injury or medical/surgical intervention as a result of the event.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: 8669619
• Report Number: 9612164-2019-02157
• Device Sequence Number: 2494945
• Product Code: MAF
• UDI-Device Identifier: 00613994798473
• UDI-Public: 00613994798473
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2019

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: 04/11/2019
• Device Model Number: INT30009UX
• Device Catalogue Number: INT30009UX
• Device Lot Number: 0008580056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 07/31/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/15/2019; 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR