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

Model Number 1550300-08

Device Problems Difficult to Insert (1316); Material Separation (1562); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to insert and the reported deformation due to compressive stress were unable to 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 other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.Further manipulation resulted in the noted stretched tip and ultimately resulted in the reported tip separation; thus resulting in the reported difficulty to insert.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.A 3.0x08mm xience sierra had difficulty being inserted onto the guide wire.The tip was noted as bent then broke off.Another same size xience sierra was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delays.No additional information was provided.

• Brand Name: XIENCE SIERRA
• 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: 9934340
• MDR Text Key: 187066332
• Report Number: 2024168-2020-03455
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227233
• UDI-Public: 08717648227233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Model Number: 1550300-08
• Device Catalogue Number: 1550300-08
• Device Lot Number: 9112741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• 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