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

Catalog Number 1074300-15

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The incident information was reviewed; however, 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 other incidents reported for this lot.The investigation determined the reported failure to advance, stent dislodgement and difficult to remove are related to circumstances of the procedure as it is likely that as the stent delivery system was advanced, resistance was met with the heavily calcified, stenosed anatomy resulting in the reported failure to advance.During retraction the stent was caught with the anatomy and the stent dislodged.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a heavily calcified lesion in the mid left main artery.A 3.0x15mm xience xpedition stent delivery system failed to cross due to the anatomy; however, when an attempt to remove the sds was made it was noted that the stent was caught with the anatomy and the stent dislodged.The physician stated that this was due to the tight and calcified lesion, not due to a device malfunction.An unspecified balloon catheter was advanced to compress the stent against the artery and a second unspecified stent was deployed over the crushed stent.The procedure was successfully completed with an unspecified device.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 7927741
• MDR Text Key: 122389350
• Report Number: 2024168-2018-07610
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162336
• UDI-Public: 08717648162336
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Catalogue Number: 1074300-15
• Device Lot Number: 8053041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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
• Patient Outcome(s): Required Intervention