MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1017275-48

Device Problems Material Rupture (1546); Activation Failure (3270)

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

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional xience stent delivery system (sds) referenced in b5 is filed under a separate medwatch report number.

Event Description

It was reported that during the angioplasty procedure, a 2.5x48mm xience stent delivery system (sds) was prepped per instructions for use and advanced to the target lesion in the moderately calcified left anterior descending (lad) artery with no resistance.Contrast was administered while pressure was applied; however, the balloon did not inflate to 10 atmospheres after 3 inflations and therefore the stent failed to deploy.A leak was observed from the distal part of the balloon.The sds was removed from the anatomy with the stent remaining on the delivery system.A 2.75x 48mm xience sds was then used however the same occurrence resulted.The sds was withdrawn with the stent remaining on the delivery system.Two new xience stents were successfully implanted.There were no adverse patient effects and there was no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 rupture and activation failure were confirmed.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported material rupture and activation failure; however, factors that may contribute to material ruptures include, but are not limited to, material damage, inflation technique, interaction with accessory devices, lesion calcification and tortuosity or insufficient preparation prior to use.Factors that may contribute to activation failure including expansion failures (inflation issues) include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, as two devices were reported for the same issue and returned with similar damage it is possible that the balloon may have interacted with accessory devices and/or the moderately calcified anatomy.This interaction may have caused damage to the balloon (pinhole), causing the reported material rupture, ultimately contributing to the reported activation failure; however, this cannot be confirmed.

• Brand Name: XIENCE PRO 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: 18876845
• MDR Text Key: 337351438
• Report Number: 2024168-2024-03120
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648191664
• UDI-Public: (01)08717648191664(17)260607(10)3061441
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1017275-48
• Device Lot Number: 3061441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 73 KG