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

Catalog Number 1076400-23

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The xience prox is currently not commercially available in the us; however, it is similar to a device sold in the us.Evaluation summary: the device was returned for analysis.Visual and dimensional inspections were performed on the returned device.The difficulty removing the protective sheath could not be replicated in a testing environment due to the condition of the returned device.The investigation was unable to determine a conclusive cause for the reported difficulties removing the protective sheath; however it is likely that the stent dislodgement occurred during removal of the protective sheath.Furthermore, the balloon shredding is likely the result of interactions with the stent as it dislodged.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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported before use of the 4.0 x 23 mm xience prox stent delivery system (sds), there was difficulty removing the protective sheath.There was concern the stent would be damaged; therefore, the device was not used.Another sds was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.The return device analysis revealed that stent implant was dislodged from the balloon and balloon shredding was observed on the distal taper.

• 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: 6230929
• MDR Text Key: 64511802
• Report Number: 2024168-2017-00176
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648164507
• UDI-Public: (01)08717648164507(17)190523(10)6051641
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2019
• Device Catalogue Number: 1076400-23
• Device Lot Number: 6051641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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