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

Catalog Number 1011709-38

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a de novo, heavily calcified and heavily tortuous vessel in the mid right coronary artery (rca).The 3.0x38mm xience prime stent delivery system (sds) could not cross the lesion due to the anatomy and the proximal shaft separated.Another 3.0x38mm xience prime sds was attempted to be used but could not cross the lesion due to the anatomy and the proximal shaft separated.A 2.75x38mm xience prime sds, smaller diameter, was attempted to be used but could not cross the lesion due to the anatomy and the proximal shaft separated.A 2.75x23mm, small size with small diameter, also failed to cross the lesion due to the anatomy and the proximal shaft separated.There was no resistance for all the sds and were simply withdrawn from the anatomy.The physician abandoned the case, however, the patient is fine and kept on medical management.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned 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.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 and heavily tortuous artery causing the reported failure to advance and subsequent shaft separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.The three additional xience prime stent delivery systems (sds) are being filed under separate medwatch report numbers.

• 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: 14522853
• MDR Text Key: 292817846
• Report Number: 2024168-2022-05703
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011709-38
• Device Lot Number: 1111742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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