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

Catalog Number 1070250-33

Device Problems Detachment Of Device Component (1104); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2017

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.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a 2.50 x 33 mm xience xpedition stent delivery system (sds) was selected for the procedure.During preparation prior to use, the proximal shaft of the sds became bent (kinked).When an attempt was made to straighten the shaft it separated into two pieces.The sds was not used in the procedure.A new non-abbott sds was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.No additional information provided.

Manufacturer Narrative

Internal file number - (b)(4).Device evaluated by mfr: correction- device status updated from returning to not returned.The device was not returned for evaluation.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 investigation determined that the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during preparation of the device ultimately contributed to the reported kinked shaft and shaft detachment prior to use.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Manufacturer Narrative

(b)(4).Correction- device status changed from not returning to returned.Evaluation summary: a visual inspection was performed on the returned device.The reported shaft detachment and kinked/bent shaft were confirmed.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during preparation of the device ultimately contributed to the reported kinked shaft and shaft detachment prior to use.There is no indication of a product quality issue with respect to the 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: 7173469
• MDR Text Key: 96725878
• Report Number: 2024168-2018-00171
• 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,Followup
• Report Date: 05/11/2018

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: 12/09/2019
• Device Catalogue Number: 1070250-33
• Device Lot Number: 6120141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Manufacturer Received: 12/17/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 02/02/2018; 05/09/2018
• Supplement Dates FDA Received: 02/09/2018; 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1