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

Model Number	1074250-08
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported deformation due to compressive stress could not be confirmed as they were 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 incidents from this lot.The stent delivery system (sds) was returned coiled in the coil dispenser with the balloon tightly folded.There was a kink in each ring of the coil dispenser at two locations.The kinks in the rings of the coil dispenser lined up consistently to the kinks and breaks on the hypotube distal to the strain relief and a break and a pinch to the inner and outer member distal to the guide wire exit notch.The investigation determined the reported difficulties appear to be related to the noted packaging damage (kinked coil and crushed chipboard box) identified during return analysis.The investigation was unable to determine a conclusive cause for the noted chipboard box and coil damage; however, factors that could contribute to packaging damage (chipboard box and coil damage) include, but are not limited to, manufacturing damage, damaged during shipping, inadequate storage and product damage during handling by user.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that after opening the 2.5 x 8 mm xience xpedition stent delivery system (sds), the stent protective sheath and stylet were noted to be bent.The sds was not used in the patient and another unspecified drug-eluting stent was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.Return device analysis confirmed breaks on the hypotube at 14.2cm and 72.8cm distal to the strain relief and a break at 7.4cm and 66.8cm and a pinch to the inner and outer member 5.5cm distal to the guide wire exit notch.No additional information was provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11886777
• Report Number: 2024168-2021-04425
• Device Sequence Number: 4760558
• Product Code: NIQ
• UDI-Device Identifier: 08717648162114
• UDI-Public: 08717648162114
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: 1074250-08
• Device Catalogue Number: 1074250-08
• Device Lot Number: 9080841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1