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

Catalog Number	INT22522UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/26/2018
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
An integrity bare metal stent was attempted to be used.It was reported that the physician tried to get the stent delivery system around a tortuous curvature of the coronary arteries but was unsuccessful.When the physician retracted the delivery system back into the guide catheter, the stent dislodged.The entire delivery system, including the sheath, was removed.The stent was retained in the radial artery at the access site.The stent was removed later that same day.
Additional Manufacturer Narrative
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: 7576881
• Report Number: 9612164-2018-01358
• Device Sequence Number: 11259663
• Product Code: MAF
• UDI-Device Identifier: 00613994798725
• UDI-Public: 00613994798725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• 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): 10/18/2018

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: 12/08/2018
• Device Catalogue Number: INT22522UX
• Device Lot Number: 0008407002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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