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

Catalog Number 1070300-15

Device Problems Patient-Device Incompatibility (2682); Difficult to Advance (2920)

Patient Problem Intimal Dissection (1333)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the heavily calcified, moderately tortuous, 90% stenosed proximal left anterior descending coronary artery.A 3x15mm xience xpedition stent delivery system (sds) was advanced with resistance due to the anatomy but could only partially cross the lesion.The stent was deployed at a high pressure, and an unspecified balloon dilatation catheter was used to appose the stent to the vessel wall.That is when a dissection was noted, and a new same size xience xpedition was used to successfully cover the dissection.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number:(b)(4), permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effect of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the calcified and tortuous anatomy during advancement to the lesion causing the reported difficulty to advance.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8966020
• MDR Text Key: 156633787
• Report Number: 2024168-2019-11478
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2021
• Device Catalogue Number: 1070300-15
• Device Lot Number: 8061441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention