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

Catalog Number	RSINT35012UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.There were two detachments on the hypotube occurring at 34.5cm and approx.45.5cm distal to the strain relief.The detached portion of the hypotube was measured to approx 11cm.The hypotube material was oval and uneven on both sides of the hypotube for both detachment sites.There were numerous kinks evident along the hypotube.The transition tubing was kinked immediately proximal to the guidewire entry port.The distal shaft was kinked 2.3cm, 4.6cm and 6.5cm distal to the guidewire entry port.The stent was positioned on the balloon between the marker bands as per specifications.There was no deformation to the stent.Bunching was evident to the balloon proximal and distal pillows.Bunching of the inner shaft was visible proximal to the distal tip.There was deformation to the distal tip.
Event or Problem Description
It was reported that the physician was attempting to treat a severely calcified moderately tortuous mid cx lesion.It was reported that the physician used 2 resolute integrity rx drug eluting stents.It both cases it was reported that no damage was noted to the device packaging and no issues noted removing the devices from the hoop/tray.No issues noted during device inspection.Negative prep completed on one of the devices.The lesion was pre-dilated.During the procedure , it was reported that the devices did not pass through a previously deployed stent.Resistance was encountered.It was reported that the physician used excessive force and dottering techniques in attempting to deliver both resolute stents, fracturing the shafts during delivery.Neither device reached the target lesion.Kinks in the catheter were not straightened and no detached portion of the device remained in the patient.The lesion area was severely calcified.A non-mdt stent was then successfully deployed.No patient injury reported.
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: 6438388
• Report Number: 9612164-2017-00336
• Device Sequence Number: 16339401
• Product Code: NIQ
• UDI-Device Identifier: 00643169037106
• UDI-Public: 00643169037106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/01/2017

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: RSINT35012UX
• Device Lot Number: 0007924835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 170