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

Catalog Number 1070250-48

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562)

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

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified posterior tibial artery.A non-abbott balloon was used and the device ruptured and separated, but was able to be retrieved during sheath withdrawal.The sheath was then exchanged for another.A 4f sheath was positioned in the popliteal artery, which had been introduced via a short 6f sheath from the common femoral artery to the superficial femoral artery.Then a 2.5x48mm xience xpedition stent was advanced and stent implanted successfully without issue.During withdrawal of the delivery system resistance was met with the introducer sheath and the shaft separated.A snare maneuver was attempted but it was not possible to snare over the stent-balloon.The 4f sheath was withdrawn carefully which allowed retraction of several centimeters of the device.When the 4f sheath was completely withdrawn, the tip of the remaining shaft appeared just outside the remaining 6f sheath and the tip was trapped with a sterile clamp to successfully withdraw the entirety of the device.It was confirmed nothing was left in the patient.Due to manipulation with the sheaths, the patient had bleeding.A blood transfusion was performed.A crossover with another sheath was used with a covered stent to fully resolve the bleeding.The account states there was a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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.It was reported that the device was used to treat the tibial artery.It should be noted that the xience xpedition instructions for use (ifu) states: the xience xpedition everolimus eluting coronary stent system are indicated for improving coronary luminal diameter.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation, removal of foreign body, delayed treatment and additional treatment appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 12939095
• MDR Text Key: 284685722
• Report Number: 2024168-2021-11136
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 01/18/2022

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: 07/02/2022
• Device Catalogue Number: 1070250-48
• Device Lot Number: 9062741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• 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: 4F SHEATH; 6F SHEATH
• Patient Outcome(s): Other; Required Intervention