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

Catalog Number RSINT30038UX

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Physician was attempting to use one resolute integrity drug-eluting stent to a lesion but resistance was encountered in the guide during delivery.Excessive force was used during delivery and when being pulled back the shaft fractured.The entire device was removed.The physician had a 4.5 balloon in the coronary already and a third wire in the 7fr guide and the stent would not exit the guide, there was too much tension and when the device was pulled back the shaft broke.No injury to the patient.

Manufacturer Narrative

Evaluation codes: results other (root cause of the event could not be determined) failure to follow instructions (force was used during delivery) related to another drug/device (resistance was encountered in the guide catheter) no results available since no evaluation performed (device or procedural images not provided for review) none (device not returned for evaluation) evaluation codes, conclusions: failure to follow instructions (force was used during delivery) operational context caused or contributed to the event (resistance was encountered in the guide catheter) unable to confirm complaint (device or procedural images not provided for review) (b)(4).

Manufacturer Narrative

Evaluation results: (deformation problem) - shaft.

Event Description

Evaluation summary: the hypotube was broken 25cm distal to the strain relief.There was a kink evident 1cm proximal to the guidewire entry port.The distal tip was flared.The breaks on the hypotube were oval and jagged.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 4840813
• MDR Text Key: 5910465
• Report Number: 9612164-2015-01007
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2017
• Device Catalogue Number: RSINT30038UX
• Device Lot Number: 0007494095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1