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

Catalog Number 1070300-38

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

It was reported that the procedure to treat a 75% stenosed lesion the obtuse marginal (om) and left circumflex (lcx) artery with mild calcification and heavy tortuosity.The 3.00x38mm xience xpedition stent delivery system (sds) was advanced to the target lesion and resistance was noted with the anatomy and the hypotube of the sds became separated distal to the strain relief.Therefore, the sds was removed from the anatomy.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another xience xpedition stent was used to continue the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deformation due to compressive stress and material separation (shaft) were confirmed.The reported difficulty 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION 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: 17039988
• MDR Text Key: 316328657
• Report Number: 2024168-2023-05730
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070300-38
• Device Lot Number: 1062342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2021
• 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
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 110 KG