MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1500350-38

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The xience sierra is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was to treat a heavily calcified lesion located in the distal right coronary artery.A 3.5 x 38 mm xience sierra stent delivery system (sds) could not advance to the target lesion with the guiding catheter.The sds was removed from the guiding catheter with slight resistance when the distal struts became lifted [flared].The procedure was successfully completed with a non-abbott stent and a guideliner.There was no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported difficulty to position, difficulty to remove and material deformation (stent flare) were confirmed.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 difficulty appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7499657
• MDR Text Key: 107824654
• Report Number: 2024168-2018-03412
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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: 10/12/2020
• Device Catalogue Number: 1500350-38
• Device Lot Number: 7100541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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