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

Catalog Number	RSINT30038UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were partially expanded.A kink along the distal shaft was visible 16.3cm proximal to distal tip.Deformation was evident to the distal tip, with tip appearing uneven.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to implant a resolute integrity drug eluting stent in a patient's severely tortuous, moderately calcified proximal circumflex artery which exhibited 75% stenosis.There was no damage noted to packaging or when removing the device from the hoop/tray.No difficulties noted when removing the protective sheath.The device was inspected and negative prep was performed with no issues.It was reported that the lesion was pre-dilated and the device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device but excessive force was not used.The physician used a 6fr non mdt guide extension catheter to deliver the stent and tried multiple times to deliver the stent without success.The stent failed to get past the second bend in the artery.Upon attempting to remove the stent from the lesion, the stent became stuck and could not be retrieved into the guide extension catheter.It was reported that when the physician was pulling it into the guide catheter this likely caused the stent to begin to dislodge.Upon complete removal of the device (removing everything at once) the stent was not on the balloon.The dislodged stent was found in the brachial artery of the arm and it was removed using a snare and a long 7fr non mdt sheath.A lot of force was required to remove the stent.It was reported that the procedure was completed by stenting the artery with two smaller stents and the patient is alive with no further injuries reported.

• 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: 6983026
• Report Number: 9612164-2017-01509
• Device Sequence Number: 444904
• Product Code: NIQ
• UDI-Device Identifier: 00643169037205
• UDI-Public: 00643169037205
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 10/27/2017

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: 05/26/2019
• Device Catalogue Number: RSINT30038UX
• Device Lot Number: 0008652134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/27/2017
• 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: 71 YR