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

Catalog Number 1070350-48

Device Problems Material Separation (1562); Failure to Advance (2524); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional xience xpedition device referenced in b5 is filed under a separate medwatch report number.

Event Description

It was reported the patient had severe coronary artery disease involving bifurcations with a diagonal branch and significant calcification.Computed tomography angiography (cta) was performed after pre-dilation with a 2.5x30 balloon with kissing wires.An attempt was made to cross the anterior descending artery with a 3.5x48mm xience xpedition stent; the stent got stuck in the artery due to calcification and the distal shaft separated.The separated segment was removed along with the delivery balloon.A dissection occurred.A 3.0x23 xience alpine failed to cross and the stent was damaged, crushed due to the calcification.The stent was not implanted, a new 3.0x23 stent was implanted to treat the dissection.There was no clinically significant delay in the procedure.No additional information was provided.Returned goods analysis observed a torn exit notch and a distal separation on the 3.0x23 xience alpine stent delivery system.

Event Description

Additional info was provided subsequent to the initial filed brazil and mdr reports: it was reported the patient had severe coronary artery disease involving bifurcations with a diagonal branch and significant calcification.Computed tomography angiography (cta) was performed after pre-dilation with a 2.5x30 balloon with kissing wires.An attempt was made to cross the anterior descending artery with a 3.0x23 xience alpine stent delivery system; the stent got stuck in the artery due to calcification and the distal shaft separated; the separated segment was removed along with the delivery balloon.A dissection occurred.A 3.5x48mm xience xpedition failed to cross and the stent was damaged, crushed due to the calcification.The stent was not implanted and a new 3.0x23 stent was implanted to treat the dissection.There was no clinically significant delay in the procedure.No additional information was provided.Returned goods analysis observed a torn outermember resulting in a leak at the location of the tear on the xience xpedition.

Manufacturer Narrative

The device was returned for analysis.The reported material deformation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 device interacted with the severe coronary artery disease involving bifurcations with a diagonal branch and significant calcification during advancement causing the reported failure to advance and subsequent material deformation.Additionally, the noted delivery system damage including bunching of the inner and outer member and torn outer member appear to be related to handling and/or manipulation of the device during the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D1: updated from xience alpine everolimus eluting coronary stent system to xience xpedition 48 everolimus eluting coronary stent system d4: part/lot number updated from alpine stent 1120300-23 lot# 2071341 to xpedition 1070350-48 lot number# 2090641.Udi was corrected from (b)(4).H6: device code 4008, 1562 removed.

• 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: 18005120
• MDR Text Key: 326515450
• Report Number: 2024168-2023-11842
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070350-48
• Device Lot Number: 2090641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: XIENCE XPEDITION.
• Patient Sex: Male
• Patient Weight: 78 KG