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

Catalog Number	INT22508UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/29/2018
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 attempt was made to use one integrity rx coronary bare metal stent to treat a severely tortuous, non-calcified lesion in the left mid cerebral artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that while attempting to deploy the stent in the left mid cerebral artery that resistance was met and the stent could not reach the lesion.While removing the stent and catheter as a unit, resistance was encountered and following a tug on the stent, the stent dislodged into the carotid artery.The dislodged stent was removed using a snare.The patient is reported to be alive with no further injury post procedure.
Additional Manufacturer Narrative
Image review: photo 1: image shows a portion of a delivery system.The stent is not present on the balloon.Photo 2; image shows a 2.25*08mm bms device and a snare.On magnification of the image, a dislodged stent can be seen attached to th e snare.Photo 3; image shows a close-up image of the snare.It is not clear from the image to see the dislodged stent.Product analysis summary: the snare was loaded in the guide catheter with the dislodged stent attached to the snare.Deformation was evident to the dislodged stent.Tissue was visible in the dislodged stent.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the distal shaft 13cm proximal to the distal tip.Stretching was evident to the distal shaft.The support wire was damaged and the distal end of it was protruding through the distal shaft.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.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: 8173804
• Report Number: 9612164-2018-03685
• Device Sequence Number: 16842252
• Product Code: MAF
• UDI-Device Identifier: 00613994798688
• UDI-Public: 00613994798688
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: 06/01/2019
• Device Catalogue Number: INT22508UX
• Device Lot Number: 0008658741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 03/11/2019
• 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: 67 YR
• Patient Weight: 80