MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

Catalog Number SC6100LG

Device Problems Difficult to Remove (1528); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

During the surgery physician used a complete se iliac device to treat a lesion in the superficial femoral artery with moderate calcification and non-tortuous anatomy.Angioplasty was performed before stenting and approximately 50% stenosis remained after.The delivery system was retrieved with difficulties after stent deployment.The physician noticed strong resistance at the end of the procedure and could not pull the distal part of the delivery system into the introducer sheath.No intervention was required to aid with the removal of the delivery system and the operator did remove the delivery system together with the sheath.Delivery system deformation was noted on the inner shaft between the tip and the distal marker during device examination post removal.The device was inspected prior to use with no abnormalities noted.The device was removed from packaging, inspected and prepped per ifu instructions with no issues or abnormalities noted.The device did not pass through a previously deployed stent.The delivery system did not get caught on the stent after deployment.There was no resistance encountered during advancement to the lesion or straight after the stent deployment.There was no excessive force used during delivery or retrieval of the device.It is reported that the accessory devices (guide wire, hemostatic valve, introducer sheath) are not believed to be a contributing factor in the event.The introducer sheath utilized in the event is used with all sizes of complete se stents.Guidewire used was 0.035¿¿; it was prepped as per ifu.No issues noted with hemostasis valve.The delivery system was retracted straight to the mouth of sheath, contralateral approach.No patient injury was reported for this event.

Manufacturer Narrative

Evaluation results: (device evaluation in progress).(b)(4).

Manufacturer Narrative

Results: related to operational context (most likely to be related to the use of the device and is procedural related), deformation problem.Conclusions: operational context caused or contributed to the event (most likely to be related to the use of the device and is procedural related).(b)(4) tip labelled.

Event Description

Evaluation summary: the inner polyimide member was kinked 5.9cm, 9.1cm and 9.6cm proximal to the tip.The proximal end of the distal tip was flared and raised.The proximal marker was positioned immediately proximal to the distal marker underneath the tip material.Resistance was noted retracting the device tip into the tip of the sheath due to the raised tip material.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• 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: 4346339
• MDR Text Key: 5205658
• Report Number: 9612164-2014-01716
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P090006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2016
• Device Catalogue Number: SC6100LG
• Device Lot Number: 0007224038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• 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