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

Catalog Number	INT22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician was attempting to treat 90% ostial right coronary artery stenosis and an 80% mid right coronary artery stenosis and heavily calcified and tortuous right coronary artery.The physician selected an integrity 2.25x12mm stent.No damage noted to device packaging or issues were noted when removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was not performed.During the procedure, the lesion was pre-dilated prior to attempt to implant stent.It was reported that the stent dislodged during removal following failed delivery and was retrieved by snare.It was reported that the physician selected another integrity 2.25x14mm stent to continue the procedure.No damage noted to device packaging.The device was inspected with no issues noted.The lesion was pre-dilated.It was reported that the stent fell off in the aorta and an attempt was made to snare the stent but was unsuccessful.
Additional Manufacturer Narrative
Product analysis: the stent delivery system (sds) and dislodged stent were received for evaluation.The dislodged stent was returned stretched, bunched and deformed.Crimp impressions were visible on the exposed balloon surface.There were numerous kinks along the hypotube.The distal shaft was kinked approx.3cm distal to the guidewire entry port.There was deformation to the distal tip.
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: 6140596
• Report Number: 9612164-2016-01212
• Device Sequence Number: 1248438
• Product Code: MAF
• UDI-Device Identifier: 00613994798695
• UDI-Public: 00613994798695
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2016

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: 11/30/2017
• Device Catalogue Number: INT22512UX
• Device Lot Number: 0007843565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided; 12/16/2016
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 01/06/2017; 09/27/2017
• 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: 57 YR
• Patient Weight: 75