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

Catalog Number 1128350-28

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Inflation Problem (1310); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2020

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The xience proa device is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was to treat a mildly tortuous, moderately calcified, proximal left anterior descending (plad) artery.A 3.50x28mm xience proa met resistance with the anatomy during advancement and it was noted that there was difficulty inflating and deflating due to the placement of the buddy wire, but ultimately the stent was implanted successfully.During the removal of the stent delivery system (sds), there was resistance due to anatomy and the guide wire.The sds separated at the proximal marker of the catheter.The separated portion was successfully retrieved by performing bypass surgery.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 other 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.

Event Description

It was reported that the procedure was to treat a mildly tortuous, moderately calcified, proximal left anterior descending (plad) artery.A 3.50x28mm xience proa met resistance with anatomy during advancement and it was noted that there was difficulty inflating and deflating due to the placement of the buddy wire, but ultimately the stent was implanted successfully.During the removal of the stent delivery system (sds), there was resistance due to anatomy and the guide wire.The sds separated at the proximal marker of the catheter.The separated portion was successfully retrieved by performing bypass surgery.Additional information received subsequent to filing the initial mdr: due to the surgery there was a delay as the patient was transferred to another hospital.

• Brand Name: XIENCE PROA 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
• MDR Report Key: 10094146
• MDR Text Key: 192374426
• Report Number: 2024168-2020-04541
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Catalogue Number: 1128350-28
• Device Lot Number: 0021961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability