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

Catalog Number 1128275-23

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Damaged by Another Device (2915)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was performed to treat a bifurcated lesion at the proximal-mid left anterior descending (lad) and the proximal left circumflex (lcx) coronary arteries with heavy calcification, mild tortuosity and 80% stenosis.The 2.75x38mm xience pro a stent was implanted in the proximal-mid lad.A 2.75x23 mm xience pro a stent delivery system (sds) was advanced to the ostium of the lcx, but was unable to cross the previously implanted xience pro a stent.During removal of the 2.75x23 mm xience pro a sds, the stent became entrapped by the previously implanted stent at the proximal lad.Both stents were then retrieved into the guiding catheter without any remnants.It was noted that the deployed stent was elongated.A new 3.0x28mm xience pro a stent was successfully implanted at the proximal lad and a new 2.75x23mm xience pro a stent was implanted at the lcx.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The xience proa device is currently not commercially available in the us; however, it is similar to a device sold in the us.The additional xience proa device referenced in b5 is filed under separate medwatch report number.

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

Subsequent to the initial reports, additional information was received confirming the 2.75x38mm xience pro a was implanted in the proximal / mid lad.When the 2.75x23mm xience pro a was advanced, it interacted with this previously implanted 2.75x38 mm stent.No additional information was provided.

• 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
• 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: 18852790
• MDR Text Key: 337075223
• Report Number: 2024168-2024-02864
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TH
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1128275-23
• Device Lot Number: 3042741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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
• Treatment: 2.75X38MM XIENCE PRO A