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

Catalog Number	INT30018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: there was bunching evident on the dislodged stent.Two of the mid stent wraps were pinched and flattened.Crimp impressions were visible on the exposed balloon surface.There was deformation to the distal tip.Kinks were visible on the distal shaft.Image review: one photograph was received by the account, capturing part of the integrity 3.0 x 18 mm delivery system and the dislodged stent.There appears to be deformation to the dislodged stent.(b)(4).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 was attempting to use an integrity stent to treat a distal saphenous vein graft.It was reported that no damage was noted to the device packaging.No issues were encountered when removing the devices from the hoop/tray.The device was inspected with no issues noted.During the procedure, it was reported that the stent dislodged during delivery to/at the lesion.The dislodged stent was removed with a snare successfully.

• Brand Name: INTEGRITY RX
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6401975
• Report Number: 9612164-2017-00269
• Device Sequence Number: 10976181
• Product Code: MAF
• UDI-Device Identifier: 00613994798503
• UDI-Public: 00613994798503
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 02/15/2017

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: 11/14/2018
• Device Catalogue Number: INT30018UX
• Device Lot Number: 0008373621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/14/2017
• 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