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

Catalog Number 1070250-48

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/26/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a 90% stenosed lesion in the anterior descending artery with heavy calcification and moderate tortuosity.After pre-dilatation the 2.50x48mm xience xpedition stent delivery system (sds) was advanced to the target lesion and the stent was implanted; however, after several attempts to deflate the balloon of the sds failed to completely deflate.Therefore, excessive force was applied to remove the sds which caused the catheter of the balloon to become stretched and fractured.The sds could not be removed independently and was removed with the guidewire, guide catheter and introducer sheath as a single unit.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier- excessive force.

Manufacturer Narrative

The device was returned for analysis.The reported shaft stretching and shaft separation were confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.The reported deflation problem could not be confirmed due to the condition the device was received 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.It should be noted that the xience xpedition everolimus eluting coronary stent system instruction for use (ifu) states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.If it is necessary to retain guide wire position for subsequent artery/lesion access, leave the guide wire in place and remove all other system components.In this case, it is possible that the ifu violation contributed to the reported separation.The investigation was unable to determine a conclusive cause for the reported deflation problem; however, factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.There was no damage or leak noted to the device during the inspection prior to use, which suggests a product quality issue did not contribute to the reported difficulties.In this case, a conclusive cause for the reported deflation issue could not be determined.The reported difficulty to remove and subsequent shaft stretching and shaft separation appear to be related to operational context of the procedure.It should be noted that the force used against the ifu may have contributed to the reported shaft stretching and/or shaft separation; however, give the clinical situation this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.B5: updated event details h6: medical device problem code 1069 was removed.

Event Description

Additional information: it was previously clarified that when the excessive force was applied during removal, the shaft fractured into two parts, but the entire device was removed as a single unit.No additional information was provided.

• 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: 16818692
• MDR Text Key: 314090328
• Report Number: 2024168-2023-04352
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070250-48
• Device Lot Number: 2110141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 79 KG