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

Catalog Number	1074300-38
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Na.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed, moderately calcified lesion in the distal right coronary artery (rca).The prowater guide wire was in the distal rca and then a balance middleweight universal ii (bmwuii) guide wire was brought into the posterior descending artery (pda).The pda was stented on the bmwuii guide wire with a 3.0x38 mm xience xpedition stent, jailing the prowater guide wire.A xience xpedition stent was deployed at 10 atmospheres (atm) for 7 seconds and the guide wires were exchanged, putting the prowater into the pda and the bmwuii into the stent struts to open the side branch.The mid rca was then stented with a 3.5x38 mm xience xpedition stent at 18 atm for 15 seconds.After the procedure, the physician noted that the prowater guide wire was stripped [peeled] and damaged.No resistance was noted during the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the stent interacted with the guide wire during advancement and/or retraction through the stent struts causing the reported stripped guide wire (device damaged by another).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8809169
• Report Number: 2024168-2019-10205
• Device Sequence Number: 16224891
• Product Code: NIQ
• UDI-Device Identifier: 08717648162381
• UDI-Public: 08717648162381
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 02/13/2022
• Device Catalogue Number: 1074300-38
• Device Lot Number: 9020441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.0X38 MM XIENCE XPEDITION; 3.5X38 MM XIENCE XPEDITION; BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE; PROWATER GUIDE WIRE; 3.0X38 MM XIENCE XPEDITION; 3.5X38 MM XIENCE XPEDITION; BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE; PROWATER GUIDE WIRE
• Patient Age: 77 YR
• Patient Weight: 71