MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1074350-28

Device Problems Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385); Deformation Due to Compressive Stress (2889); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.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 during unpacking of a 3.50x28mm xience xpediition stent delivery system, the outer packaging was noted with a slight dent.As the device was being unpacked further damage was noted (dispenser hoop coil dented, delivery system (shaft) was kinked and the stent implant [broken] in two pieces).The device was never used and there was no patient involvement.Another xience xpedition was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation, deformation due to compressive stress (shaft kink), and packaging problem (kinked coil) were confirmed.The reported tear, rip, or hole in device packaging (chipboard box damage) could not be confirmed as the box was inadvertently discarded during inventory receiving.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.The investigation determined the reported difficulties appear to be related to operational context.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during unpacking of a 3.50x28mm xience xpediition stent delivery system, the outer packaging was noted with a slight dent.As the device was being unpacked further damage was noted (dispenser hoop coil dented, delivery system (shaft) was kinked and the stent implant [broken] in two pieces).The device was never used and there was no patient involvement.Another xience xpedition was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.(b)(6) 2019: per reassessment of the event details, it was confirmed that the hypotube separated in two pieces, not the stent implant.No additional information was provided.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9182666
• MDR Text Key: 172468480
• Report Number: 2024168-2019-12569
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162565
• UDI-Public: 08717648162565
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Catalogue Number: 1074350-28
• Device Lot Number: 9031241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1