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

Catalog Number 1070300-33

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

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Event, implant dates: estimated date.The device was returned for analysis.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified lesion causing the reported failure to advance and subsequent handling damage noted during return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the 3.0x33mm xience xpedition stent delivery system failed to cross the right coronary artery (rca) heavily calcified lesion due to anatomy.The device was removed without reported issues and a 2.75x28mm xience xpedition sds was successfully used in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.Subsequent returned device analysis found a guide wire exit notch tear and hypotube separation.

• 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: 11273124
• MDR Text Key: 231112513
• Report Number: 2024168-2021-00823
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JO
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2023
• Device Catalogue Number: 1070300-33
• Device Lot Number: 0042341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1