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

Catalog Number	INT35030UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
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
The physician intended to use an integrity bare metal stent to treat a lesion located in the proximal saphenous vein graft.It was reported that the lesion was severely tortuous, severely calcified with 70% stenosis.In stent restenosis was noted.No damage was noted to packaging and no issues were encountered when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was not performed.It was reported that the stent would not cross the lesion despite multiple attempts to position the integrity stent.The stent did not pass through a previously deployed stent however resistance was encountered when advancing the device but no excessive force was used.The physician also pre-dilated the lesion three times using nc balloons.Prior to last attempt to position the stent, the stent had a 4x4 gauze laying on it.When the gauze was removed it caught on the stent causing it to be stretched and deformed.
Additional Manufacturer Narrative
Kinks were evident along the hypotube of the device.There was a kink on the distal shaft approx 8.6cm proximal to the distal tip.The mid-to-distal portion of the stent had moved distally off of the distal tip of the device.The mid-to-distal segments of the stent which moved distally on the balloon were deformed and stretched with bunched struts.Crimp impressions were visible on the exposed balloon surface.Inner lumen patency was verified with a 0.015 inch mandrel advanced distally through the guidewire entry port.There was deformation to the distal tip.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.
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: 6515569
• Report Number: 9612164-2017-00490
• Device Sequence Number: 16551103
• Product Code: MAF
• UDI-Device Identifier: 00613994798602
• UDI-Public: 00613994798602
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2018
• Device Catalogue Number: INT35030UX
• Device Lot Number: 0007892184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided; 05/17/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 06/15/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 105