MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070275-48

Device Problems Difficult to Remove (1528); Failure to Deflate (4060)

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

Event Date 05/20/2021

Event Type  Injury  

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.A cine was received and reviewed by an abbott vascular clinical specialist.The review indicated that a cause for the failure of the stent delivery system (sds) balloon to deflate cannot be determined from the media.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, factors that may contribute to deflation issues include, but are not limited to, manufacturing damage, contrast mixing, bent/kinked shaft while inside the anatomy affecting the deflation lumen and/or stretched outer member (om) thereby reducing the deflation lumen.The investigation determined the reported difficulty to remove and unexpected medical intervention appear to be related to operational circumstances relating to the reported failure to deflate.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience xpedition 48 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 de novo, mildly calcified lesion in the mildly tortuous mid left anterior descending coronary artery (mlad).The 2.75x48mm xience xpedition drug eluting stent (des) system was advanced to the lesion and the stent implanted; however, the balloon would not deflate when negative was held for 10 seconds after the 1st inflation.The indeflator was switched out for a new one, but it was unsuccessful in deflating the balloon.A wire was inserted to puncture the balloon, but the balloon still would not deflate.The hypotube of the delivery system was cut and a cut guide catheter (gc) with the braided wires exposed was advanced and punctured the balloon.The stent delivery system was then able to be removed with resistance felt.A second, planned, 3.5x28mm xience xpedition des was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE XPEDITION 48 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: 12013706
• MDR Text Key: 256768033
• Report Number: 2024168-2021-05071
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2021

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: 01/21/2024
• Device Catalogue Number: 1070275-48
• Device Lot Number: 1011541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention