MAUDE Adverse Event Report: COVIDIEN LP; STENT

Model Number PXB35-05-27-135

Device Problem Device Slipped (1584)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/18/2019

Event Type  malfunction  

Event Description

A balloon mounted stent fell off its balloon inside this patient at a non-intended location.This was due to a tortuous complex vascular anatomy.While it is ideal to insert a long sheath with a tip near the intended site of balloon mounted stent deployment to help prevent stents from falling off balloons from sheer stress during device navigation, i did not feel this was safe in this patient.This patient had a difficult arch anatomy and a native brachial artery which was nearly occluded by the 6 fr brachial sheath required to perform this procedure.The patient on day one of the procedure complained of intra-procedural hand numbness because of the decrease arterial supply to her hand as shown by day one angiography.It was felt that placement of a long sheath into the descending aorta could have occluded more of the upper extremity, putting the arm at risk for severe ischemia/thrombosis, and/or cause a stroke by obstruction of the left vertebral artery.Unfortunately, in this patient, who is still smoking despite near endstage mesenteric arterial anatomy with symptoms/weight loss complications such as this can occur when attempting to intervene.Surgical removal was required for complete stent removal.No complications noted during procedure.

• Type of Device: STENT
• Manufacturer (Section D): COVIDIEN LP; 4600 nathan ln. north; plymouth MN 55442
• MDR Report Key: 8300892
• MDR Text Key: 134868488
• Report Number: 8300892
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXB35-05-27-135
• Device Catalogue Number: PXB35-05-27-135
• Device Lot Number: A634321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA