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 Material Separation (1562); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported material deformation and material separation (shaft) were confirmed.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 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, moderately tortuous and 80% stenosed lesion causing the reported failure to advance.After removal of the device the stent was noted to be damaged likely due to interaction with the difficult anatomy during attempted advancement.Additionally, the shaft was reported to be separated, the separation was noted to be oval in appearance consistent with a kink prior to separation.Handling and/or manipulation of the device during the procedure likely resulted in the reported shaft separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other xience xpedition referenced in b5 is filed under a separate medwatch report number.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat an 80% re-stenosed lesion in the anterior descending artery with heavy calcification and moderate tortuosity.The lesion was pre-dilated with a 2.50x30mm nc trek balloon dilatation catheter (bdc).Then, the 2.50x48mm xience xpedition stent delivery system (sds) was attempted to advance; however, had difficulty crossing the lesion due to the anatomy.The sds was removed and the struts of the stent were noted to be crushed and a separation was noted on the shaft.Therefore, another 2.50x48mm xience xpedition sds was attempted to be advanced to the target lesion and may have failed to cross the lesion or may have reached the lesion, but deployment was not attempted as the stent struts were crushed and the shaft was stretched.The device was removed without issue.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information has been 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: 15981057
• MDR Text Key: 306809646
• Report Number: 2024168-2022-12620
• 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
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2012741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 71 KG