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

Catalog Number	INT30030W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the delivery system balloon between the marker bands as per specifications.Deformation was evident to the 20th and 21st distal stent wraps, with struts raised and overlapping.The inner lumen patency was verified with a 0.015 inch mandrel.The distal tip was slightly flared.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 in the mid cx artery, exhibiting moderate tortuosity, moderate calcification and chronic total occlusion.There were no abnormalities reported in relation to anatomy.There was no damage noted to device packaging and no issues noted when removing the device from the hoop/tray.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 noted that stent deformation occurred in vivo during positioning/advancement.The patient is reported as alive, no injury.

• Brand Name: INTEGRITY OTW
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6871949
• Report Number: 9612164-2017-01289
• Device Sequence Number: 13653377
• Product Code: MAF
• UDI-Device Identifier: 00613994602343
• UDI-Public: 00613994602343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/21/2017

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: 04/25/2019
• Device Catalogue Number: INT30030W
• Device Lot Number: 0008600053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR