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

Catalog Number	INT35022UX
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The physician intended to use an integrity bare metal stent to treat a moderately tortuous and calcified lesion in the mid left anterior descending (lad) with 90% stenosis.No other abnormalities were reported in relation to anatomy.No damage noted to packaging, i.E.Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.The device was inspected, with no issues found.Negative prep was performed with no issues.The lesion was predilated.The device did not pass through a previously-deployed stent, resistance was not encountered when advancing the device.It was reported that there was no alleged product issue but the stent was used past its expiration date.The hospital carries consignment of integrity and currently do not have a signed consignment agreement.It was reported that routine expiration checks are carried out at the account but may have not have been the case for this event.No issues were noted during the procedure.Post procedure the patient was treated with medication.Patient is doing well - no injury.

• Brand Name: INTEGRITY RX
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6762721
• Report Number: 9612164-2017-00997
• Device Sequence Number: 1565970
• Product Code: MAF
• UDI-Device Identifier: 00613994798589
• UDI-Public: 00613994798589
• 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
• Report Date (Section B): 07/06/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2017
• Device Catalogue Number: INT35022UX
• Device Lot Number: 0007628363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/03/2017
• 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: Required Intervention