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

Catalog Number	INT22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician was attempting to use an integrity bare metal stent to treat a lesion in the lad with no tortuosity, severe coronary artery disease was noted.No issues removing the protective sheath.Device was inspected before use, no issues noted.Lesion was pre-dilated with a 2.25 balloon.Inflation device remained on neutral pressure during delivery of the device.The device passed through a previously deployed stent.It was reported that the stent dislodged in the patient during withdrawal of the device in the vessel/guide catheter.It is reported that the stent was unable to cross so guide liner and stent were removed from patient.At that point it was noted the stent was not on the balloon.After using ivus, the stent was seen at the crux of circumflex and lad, caught by previous placed stent, from another date.The dislodged stent was jailed against the wall with a balloon.Case was then stopped.Stent was not removed from the patient.
Additional Manufacturer Narrative
The stent was not present on the balloon and did not return for analysis.The balloon returned deflated with crystallized residue present inside the balloon.There was deformation to the distal tip.Numerous kinks were evident along the hypotube.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: 6386697
• Report Number: 9612164-2017-00246
• Device Sequence Number: 18983431
• Product Code: MAF
• UDI-Device Identifier: 00613994798695
• UDI-Public: 00613994798695
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2017

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: 11/30/2017
• Device Catalogue Number: INT22512UX
• Device Lot Number: 0007843565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided; 04/10/2017
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 05/09/2017; 09/29/2017
• 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: 67 YR