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

Catalog Number 1011707-38

Device Problems Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in anterior tibial artery with heavy calcification.The 2.5x38mm xience prime stent delivery system (sds) was advanced, but failed to cross the target lesion due to resistance with the anatomy.There was no adverse patient effect and no clinically significant delay reported in the procedure.The procedure was completed with balloon angioplasty.Return device analysis found multiple device separations.There was a separation noted in the support mandrel and there were 2 separations in the hypotube located 28mm and 38mm distally from distal end of hypotube jacket.The outer member was noted to be torn at the support mandrel separation.Follow up with the account reported that this was suspected to have occurred when the sds was being advanced or removed.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.A torn shaft and shaft separation were observed.The reported difficulty to advance and failure to advance could not be replicated in a testing environment as they were 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 heavily calcified lesion causing the reported difficulty to advance and ultimately the reported failure to advance.Continued handling of the device in combination with interaction with the difficult anatomy during the attempted advancement to the lesion and/or removal from the difficult anatomy likely resulted in the reported torn and separated shaft.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME LL 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: 18600927
• MDR Text Key: 334142990
• Report Number: 2024168-2024-01172
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011707-38
• Device Lot Number: 3051241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2023
• 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