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

Catalog Number 1128350-38

Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Material Too Rigid or Stiff (1544)

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

Event Date 08/02/2021

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 additional device referenced in is being filed under a separate medwatch report number.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 the that procedure was to treat a mildly calcified proximal and distal right coronary artery.The 3.5x38mm xience proa was implanted distally followed by the 4.0x12mm xience proa stent that was implanted proximally.It was noted post deployment the balloon for both stent delivery systems were extremely slow to deflate; however, the devices did fully deflate.Resistance was met during removal with the unspecified guiding catheter.Additionally, the material of the balloon was observed to be too stiff and probably did not refold properly for both stent delivery systems.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported failure to fold (refold) issue was confirmed.The reported deflation issue was not confirmed.The reported difficulty to remove could not be confirmed due to the condition the device was returned for analysis.The reported material too rigid or stiff could not be replicated in a testing environment as it was related to operational context.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 was unable to determine a conclusive cause for the reported deflation problem as the device deflated without issue or delay during return evaluation; however, factors that may contribute to deflation problems include, but are not limited to, patient anatomical morphology, patient disease state, deflation technique, contrast dilution, and inadequate connection to the deflation device.The reported difficult to remove appears to be related to operational context as resistance during retraction due to interaction with the guiding catheter likely caused the reported difficulty to remove.The interaction with the guiding catheter during retraction may have contributed to the reported refold issues and reported irregular appearance of the device (material too rigid or stiff); however, this cannot be confirmed based on the information provided.Factors that may contribute to non-uniform balloon refold and irregular appearance of the device (material too rigid or stiff) include, but are not limited to, large balloon profile, deflation technique or balloon material properties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12342222
• MDR Text Key: 267261294
• Report Number: 2024168-2021-07304
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Catalogue Number: 1128350-38
• Device Lot Number: 0033041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 125