MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK RX XIENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The nc trek balloon dilatation catheter referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a heavily calcified, heavily tortuous lesion in the mid to proximal left anterior descending (lad) artery.A 4.0mm xience stent was deployed when it was noted via intravascular ultrasound (ivus) that the stent was under deployed.The physician then used a 5.0x12mm nc trek balloon dilatation catheter (bdc) in an attempt to further post dilate the xience stent.During removal of the nc trek, the device was reportedly either caught on a stent strut or on the guide liner, some force was applied, and the shaft snapped.The balloon was pulled into the guiding catheter and the device was fully removed all at once.The device was in two pieces upon removal.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the patient anatomical morphology (extremely angulated and heavily calcified anatomy) resulted in the reported wall apposition issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9803256
• MDR Text Key: 182546334
• Report Number: 2024168-2020-02115
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XIENCE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention