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

Catalog Number 1011710-33

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

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 similar incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified, mildly tortuous artery causing the reported failure to advance and subsequent stent dislodgement with additional therapy/non-surgical treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the heavily calcified, mildly tortuous tibial artery.Without predilatation, a 3.5x33mm xience prime stent delivery system (sds) failed to cross due to the anatomy, and the stent partially dislodged.The sds was being removed when another 3.5x33mm xience prime sds was opened.The first sds was removed, and the stent was noted to have dislodged completely within the patient.Multiple snares were used to remove the stent from the patient, and the procedure was complete.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE PRIME
• 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: 10627214
• MDR Text Key: 209804812
• Report Number: 2024168-2020-08251
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Catalogue Number: 1011710-33
• Device Lot Number: 9050741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR