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

Catalog Number 1500250-12

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Patient-Device Incompatibility (2682); Material Deformation (2976)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the circumflex (cx) artery, middle third, with de novo, heavy calcification and mild tortuosity.The 2.5x12mm xience sierra stent delivery system (sds) failed to cross the lesion and was noted with resistance in the recoil, creating difficulties in the removal.The physician confirms the anatomy contributed significantly in the resistance during advancement but does not know whether it is just the anatomy.There was resistance with the anatomy upon removal.The sds was removed independently.Upon removal, the stent was noted to be flared in the proximal part.Another xience sierra was used to complete the procedure.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 returned for analysis.The reported material deformation was confirmed.The reported failure to advance and difficulty to remove could not be replicated in a testing environment as they were both 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.H6: medical device problem code 2682 was removed.

• Brand Name: XIENCE SIERRA 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: 15152146
• MDR Text Key: 301171091
• Report Number: 2024168-2022-08480
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500250-12
• Device Lot Number: 1041441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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