MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number	RSINT25008UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review: one photo was received from the account, capturing what appears to be the resolute integrity 2.5x8mm stent.Stent deformation is visible to the 4th and 5th stent wraps with struts raised.The stent deformation can be confirmed as reported by the account.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
Stents were previously implanted in the distal lad.It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a heavily calcified and tortuous mid lad lesion exhibiting 80% stenosis.There was no damage noted to the device packaging.No issues were noted upon removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed successfully.The lesion was pre-dilated.During the procedure, it was reported that the device did not pass through a previously deployed stent.Resistance was encountered while attempting to advance the stent but no excessive force used.It was reported that stent deformation occurred during positioning.It was reported that the stent strut was fractured.It was reported that the stent was most likely damaged when attempting to cross stenosis.The artery was reported to be heavily calcified.No patient injury reported.Procedure was not completed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6596488
• Report Number: 9612164-2017-00637
• Device Sequence Number: 19152154
• Product Code: NIQ
• UDI-Device Identifier: 00643169037342
• UDI-Public: 00643169037342
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• 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
• Report Date (Section B): 05/01/2017

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: 02/03/2018
• Device Catalogue Number: RSINT25008UX
• Device Lot Number: 0007924831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/29/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 59