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

Catalog Number 1076275-18

Device Problems Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported shaft kink was able to be confirmed and a hypotube shaft separation was noted.The reported physical property issue (fragility) was unable to be confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience prox device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a moderately calcified, de novo lesion in the moderately tortuous mid left anterior descending (lad) coronary artery.While advancing a 2.75 x 18 mm rx xience pro x drug-eluting stent (des) system into the mid lad, the rx xience pro x failed to cross the calcified lesion due to patient anatomy and the proximal shaft kinked.No unusual force was applied.The device was withdrawn without difficulty.There was no visible damage to the stent itself.Reportedly, this rx xience pro x delivery system seems fragile.There were no adverse patient effects and no occurrence of a clinically significant delay.The target lesion was treated with another unspecified stent.No additional information was requested.The 2.75 x 18 mm rx xience pro x drug-eluting stent (des) system was received by the abbott vascular returned goods lab with a hypotube separation.Additional information received indicated that the site was not aware of the hypotube separation.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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: 6836646
• MDR Text Key: 85118255
• Report Number: 2024168-2017-07197
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: 1076275-18
• Device Lot Number: 7030142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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
• Patient Age: 68 YR