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

Catalog Number 1070300-48

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The stent remains in the patient.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 left anterior descending artery (lad).The 3.0 x 48 mm xience xpedition stent was deployed.During post dilatation, the stent was observed to have elongated longitudinal.A 3.0 x 48 mm xience xpedition was used for treatment.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Additional information reported that the an additional stent was not implanted for treatment; however, post-dilatation in the stretched segment was used for treatment.No additional information was provided.

Manufacturer Narrative

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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the implanted stent interacted with the balloon catheter during post dilation causing the reported stretched stent.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: 9538925
• MDR Text Key: 177362569
• Report Number: 2024168-2020-00037
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Catalogue Number: 1070300-48
• Device Lot Number: 9060641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR