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

Catalog Number 1070350-23

Device Problems Material Separation (1562); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date of event.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

There was no information provided on the complaint with the xience xpedition stent delivery system (sds).There was no reported clinically significant delay in the procedure and no adverse patient effects reported.Returned device analysis identified that the hypotube was separated 79.5 cm distal to the strain relief tubing.The fracture face was oval shaped.The separated portion was not returned.There was no other damage noted to the sds.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Exemption number e2019001.Evaluation summary: a visual inspection was performed on the returned device.The hypotube was separated distal to the strain relief tubing.The fracture face was oval shaped.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.A failure mode was not reported for the device and no information was provided; therefore, a root cause cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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
• MDR Report Key: 8910648
• MDR Text Key: 154886401
• Report Number: 2024168-2019-05574
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: 01/21/2022
• Device Catalogue Number: 1070350-23
• Device Lot Number: 9011641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1