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

Catalog Number 1076400-12

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The xience prox is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.Evaluation summary: a visual and functional inspection was performed on the returned device.The reported loose or intermittent connection was unable to be confirmed.The reported physical property issue/damages was able to be confirmed as there were cracks noted in the hub.Additionally when the device was pressurized, fluid leaked out of the cracks in the hub.As there was contrast in the inflation lumen consistent with preparation, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during preparation the inflation device was over torqued during connection to the hub resulting in the noted flash and cracks on the hub (reported physical property issue) thus resulting in the reported loose or intermittent connection.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 from this lot.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported that a 4.0 x 12 mm xience pro x stent delivery system (sds) was unable to be connected to the indeflator because the port on the hub was damaged and could not be properly screwed onto the luer lock connector on the indeflator.The sds was not used in the patient and there was no patient involvement.A new device was used for the procedure.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.Returned device analysis indicated that the connection port of the hub was cracked and the pressure test confirmed a leak at the port.

• 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: 6635788
• MDR Text Key: 77512484
• Report Number: 2024168-2017-05003
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648164477
• UDI-Public: (01)08717648164477(17)200208(10)7013141
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: 1076400-12
• Device Lot Number: 7013141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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