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

Catalog Number	INT35018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the physician was attempting to use an integrity bare metal stent.No damage was noted to device packaging and no issues removing the device from the hoop / tray.The device was inspected with no issues noted.Negative prep was performed successfully.Lesion site was internal iliac, exhibiting 90% stenosis and 45 degree angle.The stent was inspected post removal of the protective sheath, no issues reported.The inflation device did not remain on neutral pressure during delivery of the device.It was reported that the stent dislodged after getting caught on previously implanted stents in place.It was reported that nothing would cross and the stent had to be retrieved using a snare.No clinical sequelae reported.
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: 6236267
• Report Number: 9612164-2017-00030
• Device Sequence Number: 19042876
• Product Code: MAF
• UDI-Device Identifier: 00613994798572
• UDI-Public: 00613994798572
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: 05/10/2018
• Device Catalogue Number: INT35018UX
• Device Lot Number: 0008046295
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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
• Patient Age: 63 YR
• Patient Weight: 88