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

Catalog Number UNK XIENCE

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 07/30/2023

Event Type  Injury  

Event Description

It was reported the procedure was to treat a chronic total occlusion of the left anterior descending (lad) artery.A 2.50x28mm xience stent was implanted in the first obtuse marginal (om1) with minimal protrusion of the proximal part of the stent into the main left circumflex (lcx) followed by post dilatation of the stent with a 2.75x12mm nc trek balloon dilatation catheter (bdc).A 2.50x18mm xience stent delivery system (sds) was advanced to the distal second om (om2) with difficulties.The sds did not cross the mid lcx and during retraction of the sds some resistance was noticed.The stent dislodged at the mid part of the lcx at the level of the previously deployed om1 stent.The guide wire was still in its original place through the dislodged stent therefore multiple attempts were made to retrieve the dislodged stent by twisting the wire however this resulted in the dislodged stent entangling with the proximal part of the deployed xience stent.During aggressive pullback and manipulation, the proximal part of the deployed stent was spring folded and resulted in part of the stent being pulled all the wat to the left main (lm).Furthermore the proximal part of the dislodged stent was embedded in the om1 stent while the distal part remained in the om2.At this point, the decision was made to remove both stents and guiding catheter all together if possible.Another access was made and a second guiding catheter was placed near the lm.A non-abbott balloon was able to pass through the dislodged stent.It was then inflated distal to the stent and then carefully the entire system including the guiding catheter was withdrawn pulling both stents out of the coronaries.A minor surgical intervention was performed on the femoral artery access site to remove the devices.The om1 was completely dissected therefore a new 2.50x32mm xience stent was implanted as treatment.No additional information was provided.

Manufacturer Narrative

B3: date of event estimated as 7/30/2023.D4: the udi is not known as the part and lot number were not provided.Literature attachment: article title: "successful simultaneous retrieval of two dislodged and entangled intracoronary stents using distal balloon inflating technique.".Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional vascular device referenced in b5 is filed under separate medwatch report number.

• Brand Name: XIENCE 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: 19095539
• MDR Text Key: 340008629
• Report Number: 2024168-2024-04606
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male