MAUDE Adverse Event Report: ABBOTT VASCULAR-TEMECULA XIENCE ALPINE STENT; CORONARY DRUG-ELUTING STENT

Model Number 111125350-28

Device Problem Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2015

Event Type  malfunction  

Event Description

Patient had a tight lesion in her circumflex.Ptca was performed prior to the attempt to place a stent.After ivus and pre dilatation of the vessel, a 3.5 28mm xience alpine stent was used.The physician tried several time to get the stent to cross the lesion with no success.He then tried to remove the unit and it would not come out.The physician tried again and that is when the stent came off the balloon and was stuck in the proximal left main.An attempt was made to remove the stent with retrieval snares.After several unsuccessful attempts the open heart surgeon was called to consult on the possible options.It was decided that they would take the patient to open heart and retrieve the stent and by pass the cx at the same time.Patient did well post - surgery and should make a full recovery.

• Brand Name: XIENCE ALPINE STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR-TEMECULA; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 5038262
• MDR Text Key: 24365273
• Report Number: 5038262
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/21/2018
• Device Model Number: 111125350-28
• Device Catalogue Number: 1125350-28
• Device Lot Number: 5051841
• Other Device ID Number: S21721
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 78