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

Catalog Number 1070350-28

Device Problems Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976); Failure to Deflate (4060)

Patient Problem Vascular Dissection (3160)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

The device is returning for analysis.It has not yet been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 70% stenosed lesion in the proximal left anterior descending (lad) coronary artery.The 3.50x28mm xience xpedition stent delivery system was advanced to the lesion without issue and the stent implanted; however, the delivery system balloon failed to deflate.Multiple unsuccessful attempts were made to deflate/perforate the balloon.Finally the delivery system separated leaving the non-deflated balloon in proximal lad.After many trials to remove the balloon, it was successfully removed by trapping the balloon and removing it with the guide catheter.The stent was noted to be slightly deformed so some additional post-dilatation of the stent was performed.A proximal lad dissection was observed and another stent was implanted, successfully resolving the perforation.The patient did not experience any adverse sequela and a clinically significant delay in procedure was not reported.No additional information was provided.

Manufacturer Narrative

The stent delivery system was returned for analysis without the stent as the stent was implanted.The reported material separation was confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.The reported material deformation could not be confirmed as the stent was not returned for evaluation.The reported failure to deflate could not be confirmed due to the condition the device was received for evaluation.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 reported patient effect of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported failure to deflate.The shaft separation, material deformation, difficulty to remove and patient effect of dissection appear to be related to operational context of the procedure.Additionally, the reported treatments and removal of a foreign body appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE XPEDITION 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: 14357858
• MDR Text Key: 291393107
• Report Number: 2024168-2022-05134
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070350-28
• Device Lot Number: 1113041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 93 KG