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

Catalog Number 1128400-23

Device Problems Deflation Problem (1149); Difficult to Advance (2920)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The xience proa device 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 a left circumflex to left main lesion.A 4x23 mm xience proa stent was used in the circumflex artery and deployed at around 12 atmospheres partially reaching the left main.There was resistance advancing due to calcification.The stent-balloon took a very long time to deflate but ultimately partially deflated.The partially deflated stent-balloon (still partially inflated) was enough to be accommodated by a 7 fr guide catheter and simply withdrawn.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Event Description

It was reported that the procedure was to treat a left circumflex to left main lesion.A 4x23mm xience proa stent was used in the circumflex artery and deployed at around 12 atmospheres partially reaching the left main.There was resistance advancing due to calcification.The stent-balloon took a very long time to deflate but ultimately partially deflated.The partially deflated stent-balloon (still partially inflated) was enough to be accommodated by a 7fr guide catheter and simply withdrawn.There was no adverse patient effect and no clinically significant delay.Subsequent to the initially filed mdr report, the account confirmed the xience proa stent was inflated once at 14 atmospheres rather than 12 atmospheres as previously reported.The stent-balloon was inflated for around 20-30 seconds before deflation was initiated.Additionally, it was confirmed that a very long time was held negative to deflate the balloon, although a specific time was not provided.No additional information was provided.

Manufacturer Narrative

A visual, functional, and dimensional inspection was performed on the returned device.The reported deflation problem was not confirmed.The reported difficult to advance could not be tested as it was based on operational circumstances.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.The investigation was unable to determine a conclusive cause for the reported deflation problem; however, factors that may contribute to deflation problems include, but are not limited to, inflation/deflation technique, contrast concentration, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.It is possible the balloon was not allowed sufficient time to deflate before an attempt was made to withdrawal the device, resulting in the reported deflation problem; however, this cannot be confirmed.In addition, it is likely the reported difficult to advance was due to interaction with the calcified anatomy during advancement as resistance was noted.Further manipulation of the device during advancement and retraction likely contributed to the noted stretching and bunching to the inner/outer member in addition to the stretched guide wire exit notch.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.Na.

• 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: 12354182
• MDR Text Key: 267681611
• Report Number: 2024168-2021-07387
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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 Expiration Date: 05/18/2024
• Device Catalogue Number: 1128400-23
• Device Lot Number: 1050361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7 FR GUIDE CATHETER; 7 FR GUIDE CATHETER