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

Catalog Number 1011708-33

Device Problems Break (1069); Difficult To Position (1467); Unstable (1667); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.Xience pro x is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a mildly calcified lesion in a mildly tortuous mid left anterior descending coronary (lad) artery.A 2.75x33mm xience pro x stent delivery system (sds) was advanced but did not cross due to the stent feeling heavy, not smooth, and unusual during advancement into an unspecified guiding catheter.It was reportedly unable to be advanced through the guiding catheter, resulting in fractured / broken stent struts at the front of the stent (but no separation of stent or struts) and the inability to visualize the marker as the stent had shifted on the balloon, covering a balloon marker.The sds was able to be withdrawn without resistance.No other device or procedure issues were noted.The patient was treated with a 2.75x33 non-abbott stent.The patient experienced no untoward effects as a result of the failure to cross and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Corrections to lot # and catalog #.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 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.

Event Description

Subsequent to the initial filed medwatch report, additional information was received indicating that the complaint device is a 2.75x33mm rx xience prime, not a 2.75x33mm xience pro x, as initially reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported shaft kink was able to be confirmed.The reported difficulty to position using a guiding catheter, the reported difficulty to position/visibility and the reported physical property issue/irregular texture were unable to be 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 similar incidents from this lot.The reported difficulty to position/visibility could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, the abbott vascular returned goods lab received the 2.75x33mm rx xience prime stent delivery system in the following condition: there were kinks in the proximal shaft, but there was no damage or break noted to the stent implant as reported.Additional information received confirmed that the correct device had been returned and that the physician meant only that the proximal shaft was kinked / bent and the marker was difficult to visualize.There was no issue with the stent implant itself; it was not damaged or broken and had not shifted.No additional information was provided.

• Brand Name: XIENCE PRIME 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: 6456799
• MDR Text Key: 71898761
• Report Number: 2024168-2017-02786
• 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,Followup,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Catalogue Number: 1011708-33
• Device Lot Number: 6070741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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