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

Catalog Number	RSINT30015UX
Medical Device Problem Codes	Inaccurate Delivery (2339); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cine image review: the images capture the lesion site in the mid rca lesion exhibiting 95% stenosis as reported by the account.A previously deployed stent is visible in the proximal rca.The lesion site was pre-dilated with an unidentified balloon.The images appear to capture the possible attempted delivery of the resolute integrity 3.0 x 15mm stent.In the next images, the dislodged stent is clearly visible in the previously deployed stent in the proximal rca.The images however do not capture this dislodgement or the subsequent removal of the delivery system.A number of unidentified balloons are then used to jail the dislodged stent to the vessel wall and a subsequent stent is deployed.The reported deployment of the dislodged stent is not captured by the images com: (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
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and slightly tortuous mid rca lesion exhibiting 95% stenosis.It was reported that no issues were noted to the device packaging or issues encountered when removing the device from the hoop / tray.The device was inspected and negative prep performed with no issues noted.No issues noted when removing the protective sheath, the stent was inspected post removal of sheath with no issues noted.The lesion was pre-dilated.The stent passed through a previously deployed stent.The inflation device remained on neutral pressure during delivery of the device.Resistance was encountered while advancing the device but no excessive force used.It was reported that while maneuvering the stent through the previously deployed stent , the stent dislodged in the proximal rca.It was reported that the physician passed the balloon back through the stent and deployed the stent in the proximal rca.The proximal rca was then restented successfully with another 3.0x15mm resolute integrity stent.The physician then used a guideliner through both proximal stents and delivered a new stent to the original mid rca lesion successfully.Patient reported as well with no adverse events.
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: 6240278
• Report Number: 9612164-2017-00038
• Device Sequence Number: 19039811
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: 08/27/2018
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008196077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 80 YR
• Patient Weight: 81