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

Catalog Number	INT27526UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use an integrity rx stent.No abnormalities were reported in relation to anatomy.No damage was noted to packaging.No issues were noted when removing the device from the hoop.No difficulties were noted when removing the protective sheath.The device was inspected with no issues found after the protective sheath was removed.Negative prep was performed with no issues.It was reported that stent dislodgement occurred during delivery to the lesion.The stent was crushed against the vessel wall.The stent was not removed from the patient and so remains in the patient.The device did not pass through a previously-deployed stent.No excessive force was used during delivery.No patient injury is reported.
Additional Manufacturer Narrative
Correction from initial mdr: there were no further injuries reported post procedure.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: 7209075
• Report Number: 9612164-2018-00121
• Device Sequence Number: 13760400
• Product Code: MAF
• UDI-Device Identifier: 00613994798879
• UDI-Public: 00613994798879
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 01/22/2018

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: 07/10/2019
• Device Catalogue Number: INT27526UX
• Device Lot Number: 0008707393
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 01/22/2018
• 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