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

Catalog Number 1011707-18

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a re-stenosed lesion located in the anterior tibial (at) artery that was heavily calcified and moderately tortuous.A xience prime stent delivery system (sds) was advanced over the wire to the target lesion in the at, but the sds would not cross the lesion and was manipulated on the wire back and forth.When the sds was removed from the patient, the proximal shaft snapped in half, outside the patient.The lesion was ballooned with an armada 14 and to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported failure to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.Additionally it was noted that there were multiple kinks on the outer member and bayonet/support wire, and the guide wire exit notch was torn.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 as it is likely that resistance was met with the heavily calcified and moderately tortuous anatomy resulting in the reported failure to advance and the reported difficult to remove.Manipulation of the device resulted in the noted device damages (multiple kinked outer member and bayonet/support wire, torn guide wire exit notch) and ultimately resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6; medical device problem code: 1494 - device was not used off label.

• Brand Name: XIENCE PRIME 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
• MDR Report Key: 11664619
• MDR Text Key: 247685364
• Report Number: 2024168-2021-03111
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Catalogue Number: 1011707-18
• Device Lot Number: 0031841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1