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

Catalog Number INT27518UX

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2013

Event Type  malfunction  

Event Description

It was intended to use an integrity 2.75 x 18 mm rx bare metal stent to treat a 15 mm lesion in the lad vessel.The device was removed from the hoop with no difficulties.The vessel is reported as having moderate tortuosity and little calcification.It is unknown if the protective sheath was grasped at the distal end with the thumb and finger, excessive force however had not been used during positioning.The balloon system was inflated in the vessel.It was then realized that the stent was not present on the delivery system.It is reported that this probably occurred when the protective sleeve was being removed during prep, prior to the delivery system being used in the patient.The physician commented that stent felt more flexible than usual when he had loaded it onto the wire.The stent was discovered just outside the proximal end of the protective sheath, still on the mandrel.The stent was not used in the patient but the delivery system was.There were no reported patient complications.Evaluation summary: the distal tip was flared.The distal end of the sheath was bunched and positioned over the loop of the stylette.The stent was returned positioned on the stylette along with the sheath.The 5th, 6th and 7th distal stent segments were deformed with a number of raised struts.The stent was pinched and slightly flattened.There was crystallized residue present in the inflation lumen and balloon.The balloon folds were opened.

Manufacturer Narrative

Evaluation results: failure to follow instructions (ifu contravened).Incorrect technique/procedure (procedural related).Evaluation conclusions: failure to follow instructions (ifu contravened).Operational context caused or contributed to the event (procedural related).(b)(4).

• Brand Name: INTEGRITY RX
• Type of Device: STENT, CORONARY
• 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: 3662283
• MDR Text Key: 20295405
• Report Number: 9612164-2014-00204
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030009
• 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
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2014
• Device Catalogue Number: INT27518UX
• Device Lot Number: 0006248647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• Date Device Manufactured: 07/02/2012
• 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