MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012535-100

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 6.0x200 mm armada 18 and supera referenced are being filed under separate medwatch mfr numbers.

Event Description

It was reported that the 6.0 x 200 mm armada 18 was inflated for the first time at 8 atmospheres in the heavily calcified superficial femoral artery (sfa) without incident.A supera was implanted in the mid sfa followed by the 7.0x100 mm absolute pro vascular stent in the proximal/ostium sfa.The same armada 18 was inserted to post dilate a segment of the supera stent where three very fibrotic segments were observed to not completely yield.The armada 18 was inflated to 14 atmospheres when the balloon ruptured and separated in the anatomy.There was difficulty removing the ruptured armada past the absolute pro stent, resulting in the stent becoming smashed/deformed.The stent was also moved partially into healthy tissue during the attempt to remove the armada.A non-abbott diagnostic catheter was inserted to remove the separated armada segment.The fractured armada was successfully retracted into the tip of the sheath along with the guide wire that had some of the armada on it as well.All the devices were removed as a unit.There were no armada fragments left in the patient.A 7.0x20 mm absolute pro vascular stent was implanted in the ostium over the damaged segment of the first absolute stent.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).The product was not returned for analysis.A review of the lot history record and similar incident query could not be performed because the lot number was not provided.The investigation determined the reported difficulties of migration of the device, device damaged by another device and material deformation appear to be related to circumstances of the procedure.During removal of the ruptured balloon, resistance was felt with the absolute pro stent resulting in the stent to deform and to migrate from the intended location into healthy tissue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8298540
• MDR Text Key: 134786641
• Report Number: 2024168-2019-00778
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012535-100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: SUPERA, BALLOON CATHETER: ARMADA 18; STENT: SUPERA, BALLOON CATHETER: ARMADA 18
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR