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

Catalog Number 1500350-33

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported material deformation was confirmed.The reported difficulty to advance could not be confirmed due to the condition the device was returned for analysis.Additionally, the following was noted: the distal tip was torn.The proximal end of the stent implant was located distal to the distal end of the proximal balloon marker.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 crimp marks were visible on the proximal marker where the stent implant was initially crimped, suggesting the stent was originally positioned correctly and securely at the time of manufacture.The investigation determined the reported and noted difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guide catheter during advancement causing the reported difficulty to advance, subsequent material deformation and noted tear in the distal tip.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 to treat an unspecified lesion.An attempt was made to insert the 3.5x33mm xience sierra drug eluting stent system(des) into the non-abbott guiding catheter but resistance was met, and the stent became deformed.There were no adverse patient effects and no clinically significant delay in the procedure.Another xience sierra was used to successfully complete the procedure.Return device analysis noted the distal tip was torn and the stent moved on the delivery system.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 10333839
• MDR Text Key: 200656431
• Report Number: 2024168-2020-06252
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Catalogue Number: 1500350-33
• Device Lot Number: 8101341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEZILLA GUIDING CATHETER