MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070300-48

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Prolapse (2475)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effect(s) of thrombosis is listed in the xience xpedition 48 everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a proximal left anterior descending (lad) 75% stenosed lesion and a percutaneous coronary intervention (pci) was performed.A 3.0x48mm xience xpedition stent (1070300-48, 9082841) was implanted in the proximal lad with acceptable results.Reportedly, post-implantation, there was intra-stent plaque protrusion and thrombus.As treatment, additional dilatation was performed.0% residual stenosis and timi grade iii was observed post-procedure.On (b)(6) 2020, the patient started experiencing chest pain.On (b)(6) 2020, a cardiac magnetic resonance imaging (mri) was performed.5-10% ischemia was observed in the lad territory.On (b)(6) 2021, another diagnostic pci was performed.Reportedly, the xience xpedition stent had remained patent, without any disease progression, and there was no device malfunction.No treatment was required.Per physician, the event was unrelated to the xience xpedition stent.No additional information was provided regarding this issue.

• Brand Name: XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11305017
• MDR Text Key: 233044357
• Report Number: 2024168-2021-01036
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Catalogue Number: 1070300-48
• Device Lot Number: 9082841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 72